BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1655007 · Received April 9, 2010

    Report

    Report Number
    2015691-2010-13093
    Event Type
    Death
    Date Received
    April 9, 2010
    Date of Event
    January 27, 2010
    Report Date
    March 11, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED; NOT AVAILABLE FOR EVALUATION. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAS ANOTHER RELATED EVENT; (B) (4). THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION, THE OPERATIVE REPORT AND DISCHARGE SUMMARY WAS RECEIVED. 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

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. ON (B) (6) 2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), A RESPONSE WAS RECEIVED. THROUGH THE DISCHARGE SUMMARY, IT WAS LEARNED THAT THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF 2 DAYS FROM "VASCULAR COLLAPSE AND ACUTE RESPIRATORY FAILURE/ APNEA. THE FAMILY DID NOT WANT AN AUTOPSY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P R-09K2344

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death