BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1913234 · Received December 2, 2010

    Report

    Report Number
    2015691-2010-14470
    Event Type
    Death
    Date Received
    December 2, 2010
    Date of Event
    September 7, 2010
    Report Date
    November 2, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    PATIENT AND/OR DEVICE STATUS IS REPORTED TO THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, IT NOTED ON A RETURNED IMPLANTATION DATA CARD, "CONTAMINATED" WAS NOTED. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED AT IMPLANT. PER THE OPERATIVE REPORT, AFTER COMING OFF BYPASS, PROFUSE BLEEDING WAS NOTED TO BE COMING FROM THE ATRIOVENTRICULAR GROOVE POSTERIORLY SUGGESTING AN ATRIOVENTRICULAR DISRUPTION. THE HEART WAS REARRESTED AND THE DEVICE WAS EXPLANTED TO FACILITATE EXPOSURE. A PATCH REPAIR WAS ATTEMPTED ALONG WITH REPLACEMENT OF ANOTHER 19 MM VALVE, BUT THE PATIENT'S TISSUE WAS EXTREMELY FRIABLE AND THE REPAIR SUTURES DID NOT HOLD. UNFORTUNATELY, THE BLEEDING CONTINUED. THE PATIENT LOST HER BLOOD PRESSURE AND PASSED AWAY IN THE OPERATING ROOM. PER THE SURGEON'S RESPONSE, THERE WAS NO MALFUNCTION OF THE DEVICE, NOR DID IT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-09J2258

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death