HeartMate 3 Safety Concerns

HeartMate 3 Safety Concerns: Device Malfunctions Lead to Deaths

Amelia Ross

Fatal Choice: Mechanical Pump Troubles

Arvid Herrman, a 68-year-old Wisconsin farmer, faced a life-altering decision: a mechanical heart pump, HeartMate 3, or certain death within a year due to his inability to undergo a heart transplant. Herrman chose the pump, but a defect in its locking mechanism allegedly caused his death, as reported by his daughter Jamie Edwards in a lawsuit filed in December 2020. A similar case involving Ramon Flores Sr. further raises questions about the device’s safety.

Manufacturer’s Response: Lack of Conclusive Evidence

Thoratec Corp., the manufacturer of HeartMate 3, acknowledged a bent locking arm in both cases but asserted a lack of “direct correlation” between the device and the deaths. With over 4,500 reports since August 2017, the KFF Health News analysis reveals a complex landscape. In nearly 90% of cases, Thoratec found no issues with the device or its usage, according to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.

FDA and Manufacturer’s Assurance vs. Skepticism

Despite FDA support for the HeartMate 3, skeptics, including former FDA officials, express concern over the high number of death reports. Madris Kinard and Larry Kessler question the adequacy of the FDA’s post-market surveillance, emphasizing the need for thorough investigation and transparency. Abbott, the parent company of Thoratec, settled Herrman’s lawsuit but denies liability, while the Flores case remains ongoing.

Challenges in Device Safety Reporting

MAUDE reports reveal various adverse events associated with HeartMate 3, such as bleeding and respiratory failure. However, limitations in reporting and data transparency hinder patients, caregivers, and doctors from making informed decisions. The complexity of LVADs, combined with incomplete data in MAUDE, raises concerns about the overall safety profile of medical devices and the challenges patients face when considering life-altering treatments.