Arvid Herrman, a 68-year-old Wisconsin farmer, chose to have a mechanical pump called HeartMate 3 implanted in his heart after being too old and sick for a heart transplant. Unfortunately, the device led to his death, and a lawsuit by his daughter alleges that a defect in the device’s locking mechanism caused multiple strokes, a brain injury, and multiorgan failure. The same device was also implanted in Ramon Flores Sr., who died eight days later from air embolism strokes. Over 4,500 reports have suggested the HeartMate 3 may have caused or contributed to patient deaths. The manufacturer has denied liability and settled one lawsuit, while the other case is ongoing. The FDA’s database of device-related incidents, known as MAUDE, has limitations and may not accurately capture all device problems. As a result, patients and doctors may not have complete information to assess the risks of using the HeartMate 3. Former FDA officials and medical device experts believe more study is needed to understand the safety profile of the HeartMate 3 and other medical devices.
Source link
Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk?
