Summary: A recent KFF Health News analysis highlights concerns regarding the FDA’s database, the Manufacturer and User Facility Device Experience (MAUDE), which may be missing crucial information about the safety of the HeartMate 3, a mechanical heart pump. The device, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories, is currently the only FDA-approved device of its kind. The analysis reveals that over 4,500 reports since August 2017 suggest the HeartMate 3 may have caused or contributed to patient deaths.
Two specific cases, involving Arvid Herrman and Ramon Flores Sr., prompted lawsuits alleging that a defect in the HeartMate 3’s locking mechanism led to fatal complications. Thoratec confirmed a bent locking arm in both cases but couldn’t definitively link it to the deaths.
While the manufacturer denies liability, the FDA database shows that in nearly 90% of the reported cases, Thoratec found no issues with the device. Abbott claims that the HeartMate 3, introduced in 2017, is the safest left ventricular assist device (LVAD) to date, but safety experts and former FDA officials express concerns.
The FDA, as recently as August, expressed support for the device, emphasizing its benefits for patients with few alternatives. However, safety experts, including former FDA officials, argue that the high number of death reports should be considered a safety signal, indicating potential issues that require further investigation.
Critics highlight limitations in the reporting system, noting that not all device problems are reported to MAUDE, and submitted reports may lack accuracy or completeness. This raises concerns about patients and caregivers being inadequately informed about the risks associated with devices like the HeartMate 3. Medical professionals, too, may find it challenging to use the FDA database to counsel patients effectively. The article suggests that ongoing scrutiny and more in-depth study of the reported deaths are necessary to ensure patient safety and address potential concerns with the HeartMate 3.