FDA warns of dangerous errors made during implantation of Abbott's MitraClip (Dr. Danny Dvir)
Abbott ($ABT) said it will retrain implanters of its transcatheter MitraClip device for mitral valve repair following reports of procedures in which the implant could not be detached from the delivery device. All 9 reported cases resulted in surgical interventions, and one ended in postoperative death due to severe comorbidities.
And the FDA publicized the company's Feb. 4 field notice, a sign that the agency believes the issue is critical to patient safety. There are 3,543 MitraClips on the market, the FDA said, including 2,246 outside the U.S.
In spite of the recent field notice, MitraClip faces the “opposite” issue, Dr. Danny Dvir of St. Paul's Hospital in Vancouver said.
Varun Saxena reports
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