FDA Probes MicroMed Cardiovascular

The U.S. Food and Drug Administration (FDA) is looking into whether MicroMed Cardiovascular, which received a warning letter from the agency in December, should have reported a death that could allegedly be related to the DeBakey VAD Child Device.

“Significant deviations include failure to report to the FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that your marketed device may have caused or contributed to a death or serious injury,” the letter says.

A MicroMed official said the device did not cause the 4-year-old cancer patient’s death and that the child eventually died from chemotherapy complications, according to published reports.

MicroMed received FDA approval in 2004 for device, which is implanted in the patient’s chest.