Thousands of Patients Were Implanted With Heart Pumps That the FDA Knew Could Be Dangerous

[Nevilledog]

Link to tweet

Tweet text:
Ken Armstrong
@bykenarmstrong
The FDA found problems with a heart pump in 2014, 2015, 2016, 2017, 2018.

It met with the manufacturer >100X.

But the FDA never penalized the company, which kept selling the pump, while the FDA received >3,000 reports of deaths.
@_neilbedi @propublica

Thousands of Patients Were Implanted With Heart Pumps That the FDA Knew Could Be Dangerous
Inspectors repeatedly found manufacturing and device quality problems with the HeartWare heart pump. But the FDA did not penalize the company, and patients had the device implanted on their hearts...
propublica.org
8:36 AM · Aug 5, 2021

https://www.propublica.org/article/heartware-patients-implanted-fda

John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular Assist Device, or HVAD, could be implanted in Winkler’s chest until a transplant was possible. The heart pump came with disclaimers of risk, but Winkler wanted to fight for time. He was only 46 and had a loving wife and four children, and his second grandchild was on the way.

So, in August 2014, Winkler had surgery to implant the device. A golf-ball-sized rotor was attached to his left ventricle to pump blood through a tube and into his aorta. A cable threading out of a small incision in his waist connected to a battery-powered controller strapped to his body. If something went wrong, an alarm as loud as a fire drill would sound.

Winkler returned home weeks later and, as he regained his strength, became hopeful about the future. He started making plans to visit colleges with his daughter, and was able to host his parents and new grandchild for Christmas. “He was doing so much better,” his wife, Tina Winkler, said. “We thought he was coasting until he got his transplant.”

What John Winkler didn’t know: Months before his implant, the Food and Drug Administration put HeartWare on notice for not properly monitoring or repairing HVAD defects, such as faulty batteries and short circuits caused by static electricity, that had killed patients. The agency issued a warning letter, one of its most serious citations. It demanded fixes within 15 days, but took no decisive action as problems persisted.

*snip*

[50 Shades Of Blue]

1. Who was on the take...

[EYESORE 9001]

2. What kind did Darth Cheney get?

Betcher ass he didn’t get one of these.

[luv2fly]

3. The same FDA we want to approve Covid vaccines so that people feel better about them?

This story won't help.