a heart pump is a life-sustaining medical device

August 5, 2021 5:21 PM

Thousands of Patients Were Implanted With Heart Pumps That the FDA Knew Could Be Dangerous. (ProPublica, Aug. 5, 2021) As HeartWare and Medtronic [which acquired HeartWare in 2016] failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so. The HeartWare Ventricular Assist Device [HVAD] was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards.

The HVAD was first approved for commercial distribution in November 2012.

In July 2015, human trials began for HeartWare's second heart pump, the Miniaturized Ventricular Assist Device [MVAD]; at the end of July 2015, HeartWare stock sold for $90/share. These trials were halted after two months and only 11 implants; by mid-October, HeartWare was $35/share (setting the stage for Medtronic's acquisition less than a year later). Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD [...] the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.

September 2017: the FDA approved the HVAD as “destination therapy” for patients who were not heart transplant candidates (relying on the device for the rest of their lives)

November 2018: Medtronic settled the investor suit for $54.5 million, admitting no fault

By December 31, 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA. On June 3, 2021, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.

When Medtronic stopped the distribution and sale of the HVAD System in June, the HVAD had collected a total of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death. The others are "Class II" recalls ("a product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death"), and the first notice is from July 2013.

By Medtronic's tally, there are approximately 4,000 patients currently implanted with the HVAD worldwide.

posted by Iris Gambol (20 comments total)

You had me at “Medtronic”

Great post, this is important information to be surfaced and discussed.
posted by armoir from antproof case at 5:33 PM on August 5, 2021 [5 favorites]

Seems to be a trend with US regulatory agencies, not just the FDA, being far too trusting of the companies they're supposed to be regulating. Just from top of mind, the FAA was far too trusting of Boeing on the 737 MAX, and the CPSC was far too trusting of Peloton when their treadmill killed a kid.
posted by meowzilla at 5:49 PM on August 5, 2021 [13 favorites]

This is the inevitable consequence of regulatory capture as a systemic issue. Some relationships need to be adversarial for the good of the public.
posted by mhoye at 6:00 PM on August 5, 2021 [27 favorites]

Seems to be a trend with US regulatory agencies, not just the FDA, being far too trusting of the companies they're supposed to be regulating.

I think it's less that the regulators trust the actual companies and more that they trust they themselves will never be held accountable for serving capital before the public.
posted by dusty potato at 6:01 PM on August 5, 2021 [7 favorites]

It's more complicated than that. Regulatory capture is 100% a thing. But regulators are also almost universally outgunned by the big companies, and in areas that require substantial and expensive technical expertise. The American public has so far not expressed a desire to fund regulatory regimes properly.

Note that the Supreme Court held relatively recently that the FDCA preempts state-law tort claims with respect to medical devices. There's no private right of action under the FDCA (as a private person, you can't bring your own suit to enforce it), so the FDA is almost the only mechanism by which it can be enforced...

Except securities law! We've created a situation in which the investors in Medtronic get more relief for being deceived about the device than the people who were injured by the device.
posted by praemunire at 6:37 PM on August 5, 2021 [34 favorites]

My wife uses a Medtronic insulin pump. The warranty period is 4 years. She is on pump #10. That is nine failed devices. They have about 70% of the market, which makes the decision to go to a different pump a little daunting.

(Edited to update numbers after checking with wife. It's worse than I thought.)
posted by COD at 7:26 PM on August 5, 2021 [12 favorites]

We are not a society, we are a plinko ball of past investments and hostages careening down a hellscape of scams and frauds and liars painted to look like a flag. I used to eschew the term evil, but knowingly selling and implanting these is evil and looking the other way as the regulator is evil and if both of those who sell and regulate say they are just obeying trusting the market then the f-ing market is evil.
posted by anecdotal_grand_theory at 8:57 PM on August 5, 2021 [22 favorites]

The invisible hand of the free market will solve this problem!
*many innocent people die because an unproven medical device was rushed to market*
Ah, well, nevertheless...
posted by Mr.Encyclopedia at 9:36 PM on August 5, 2021

To make matters worse, the initial approval for most medical devices happened once, many years ago. Each subsequent device of that type made by that company is approved as a "modification" instead of re-approving from scratch.

A modern pacemaker or artificial hip joint is essentially approved based on an initial evaluation that may be decades old. This is essentially the same situation as the FAA's approval of the 737 Max.
posted by monotreme at 10:31 PM on August 5, 2021 [3 favorites]

I’ve had years of bad experiences with medtronic’s diabetes division. I’m so grateful that their pacemaker division seems ok given that it keeps a family member alive. As a company they seem to thrive on under delivering and still somehow selling.

@COD I’m happy to recommend the pump from Tandem Diabetes as an excellent option compared to the dangerous garbage sold by Medtronic. Combined with a Dexcom glucose sensor it is unbeatable. That Medtronic has such a large share of the market should give confidence and comfort, but instead I’m sad for the majority of insulin pump users who are saddled with Medtronic’s inaccurate claims that their sensors “work” and that their pumps are reliable.
posted by pkingdesign at 12:53 AM on August 6, 2021 [6 favorites]

The "Slipped Through The Cracks" section near the bottom, about the crappy system for notifying patients when devices have serious problems, is just insane:

The FDA typically issues a public notice, while health professionals contact their patients. But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.

When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.

Patients can find warning letters online in a searchable database of thousands of letters from different FDA divisions, including the center for devices. But HeartWare’s 2014 letter is no longer available for public review because the website purges letters older than five years.

Don't miss the next part, about the 2008 Supreme Court decision barring patients from suing device makers in state court - because, you know, the FDA is so rigorous and all.

Great post, and great article - one that makes me happy I donate regularly to ProPublica. One of the sharpest investigative journalism outlets around.
posted by mediareport at 4:15 AM on August 6, 2021 [11 favorites]

Thanks for this post. I just can't even ... Thank goodness for ProPublica!
posted by Bella Donna at 5:04 AM on August 6, 2021 [1 favorite]

To make matters worse, the initial approval for most medical devices happened once, many years ago. Each subsequent device of that type made by that company is approved as a "modification" instead of re-approving from scratch.

I'm an engineer in the medical device space. This is called a "510(k) submission", and we base these modifications on what we call a "predicate device". The idea is if Company X has a device on the market, and someone (Company X or Company Y) wants to improve on that, they don't have to start from scratch with clinical trials, which can be a very lengthy process. They can do supplemental V&V (verification and validation) activities and submit that to the FDA, who reviews it and comes back with either clearance (these devices are "cleared" not "approved"), a rejection, or (most commonly) a ton of questions that need to be answered (quickly).

The FDA doesn't test the products I work to develop. They look at the testing activities me and my development team conducted and make a determination of 1) did we test the right things in the right way and 2) were the results of those tests satisfactory. It's pretty extensive (function of the device, effectiveness of the cleaning during/after the manufacturing process, the packaging, the sterilization, the reprocessing (like for instruments after they're used in one procedure and before they're used in the next procedure), logistics (will FedEx break it), biocompatibility, human factors/usability, instructions for use, labeling, etc etc).

We get audited all the time, both by the FDA and by "notified bodies" (for products sold in the EU). These audits can be announced or unannounced, and they can be spurred by surgeon/patient complaints or they can stem from an audit done upstream/downstream from us. For example, they can go to the raw material supplier and audit them, find a problem with one of their material certifications, and then trace that material through its lifecycle and audit every company that comes in contact with it. I get called into a room with the auditor and have to answer a lot of questions about the decisions I've made in the past (could be a month ago, could be 5+ years ago, I've learned "if you're not documenting, you're not engineering, you're just fucking around").

Regarding FDA auditors: some are fresh out of college who got their degree in regulatory affairs. Some are seasoned auditors with decades of experience and know the ins and outs of the business. I can tell some totally know their shit and like to make me feel uncomfortable when I'm in the hot seat. Some are conflict avoidant and can be stonewalled.
posted by spikeleemajortomdickandharryconnickjrmints at 6:16 AM on August 6, 2021 [13 favorites]

Another med device developer here. I agree with spikelee.. but would just like to add that besides the 510(k) where a company gets a new-to-the-market device cleared by showing it is equivalent to an already marketed device as spikelee describes, i think the text about modifications is referring to a supplement or amendment to the original 510(k) submission. There are important requirements for when a supplement or amendment is allowed versus a new 510(k) clearance.
posted by Tandem Affinity at 7:36 AM on August 6, 2021 [1 favorite]

I've learned "if you're not documenting, you're not engineering, you're just fucking around"

I also work in FDA regulated industries, and our watchword is "if you didn't document it, you didn't do it." That phrase applies to everything, from design control to validation testing to in-process inspection to batch release approval.

From my experience, I also agree with spikeleemajortomdickandharryconnickjrmints' comment. I can also say that the companies I've worked for take complying with FDA regulations seriously; I've done a lot of work revolving around companies scrambling to address observations from an FDA audit.
posted by Gelatin at 7:46 AM on August 6, 2021 [1 favorite]

Speaking of patient notification, and since posters have mentioned other Medtronic products: You can check for recalls at accessdata.fda.gov
"This database contains Medical Device Recalls classified since November 2002. Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the FDA. "
Search specific product names, or with general terms.
FDA --> Medical Device Recalls --> "Medtronic diabetes" 56 results
FDA --> Medical Device Recalls --> "Medtronic implantable pacemaker" 94 results
FDA --> Medical Device Recalls --> "Medtronic" 486 results
posted by Iris Gambol at 10:34 AM on August 6, 2021

It’s not clear that what the FDA is measuring, and therefore enforcing, is a good subset of what it could do to verify that devices are safe and helpful for their users. Plenty of half-captured systems require masses of bureaucratic labor that isn’t aligned with the purported social goal.
posted by clew at 11:41 AM on August 6, 2021 [1 favorite]

On a slight tangent, the FDA effectively ignored 1080 complaints about Allergan breast implants between 2008-2018. The following year they more than doubled, and the FDA finally ordered a recall. The FDA also finally released data about all breast implants, and it turns out there were nearly a half-million complaints on record! Women are often counseled to have “reconstruction” after cancer and a mastectomy. The majority of these involve implants. Because it’s a “women’s” problem, it gets ignored. Getting off my pedestal.
posted by dbmcd at 12:11 PM on August 6, 2021 [9 favorites]

Thank you, dbmcd. WTH: Of the 733 cases of [breast implant-associated anaplastic large cell lymphoma] BIA-ALCL reported worldwide, 620 — or 84.6 percent — were reported for Allergan implants, according to an Aug. 20, 2020, update from the FDA. In addition to the BIA-ALCL risk, these implants also had greater incidences of seromas, or fluid pockets, compared to other implants. They also carried a greater risk of performance failure, pain, rupture and scar tissue around the implant known as a capsule. [...] Allergan sold most of the recalled products under its Natrelle brand, but some Americans may have received older textured breast implants sold by McGhan and Inamed. Allergan bought these companies and became responsible for these products and all liability associated with them. McGhan and Inamed textured implants are also a part of the recall. Most cases of BIA-ALCL occur many years after receiving a textured implant, according to the FDA. So women with older implants may be at increased risk.
BIA-ALCL and textured implants.
posted by Iris Gambol at 1:24 PM on August 6, 2021

My dad has had to have two otherwise-unnecessary heart operations because of crappy hardware like this. I am very much Not A Fan.
posted by humbug at 4:25 PM on August 6, 2021 [2 favorites]