FDA database that tracks heart device harms may miss red flags, safety experts warn
FDA database that tracks heart device harms may miss red flags, safety experts warn
The HeartMate 3 is considered the safest mechanical heart pump of its kind, but a federal database contains more than 4,500 reports in which it may have caused or contributed to a patient's death.
Too old and too sick for a heart transplant, Arvid Herrman was given a choice: Have a mechanical pump implanted in his heart, potentially keeping him alive for several years, or do nothing and almost certainly die within a year.
The 68-year-old Wisconsin farmer chose the pump, called a HeartMate 3 — currently the only FDA-approved device of its kind in use. Instead of extending his life, though, the device led to his death, according to a lawsuit filed in December 2020 by his daughter Jamie Edwards.
The lawsuit alleged that Herrman died because a defect in the locking mechanism of the HeartMate 3 prevented the device from sealing, causing multiple strokes and leading to a severe brain injury and multiorgan failure. Herrman "could not have anticipated the danger this defect … created for him," the lawsuit said.
This is beyond tragic.
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