BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS

    MDR report key: 1661162 · Received April 18, 2010

    Report

    Report Number
    2015691-2010-13149
    Event Type
    Death
    Date Received
    April 18, 2010
    Date of Event
    November 5, 2009
    Report Date
    March 18, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE PATIENT ALSO HAD A PATCH IMPLANTED ON THE SAME DAY; (B) (6). INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, ADDITIONAL INFORMATION AND A COPY OF THE OPERATIVE REPORT WERE RECEIVED; HOWEVER, NO FURTHER INFORMATION REGARDING THE DEVICE OR THE REPORTED EVENT WAS LEARNED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 1.1 MONTHS, DUE TO UNKNOWN REASONS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE OPERATIVE REPORT WAS RECEIVED FOR THE SURGERY OCCURRING APPROXIMATELY 1 MONTH AND 4 DAYS BEFORE THE PATIENTS' DEATH. UNFORTUNATELY, NO INFORMATION REGARDING THE DEVICE OR EVENT WERE LEARNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-09F1376

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death