BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1707918 · Received June 2, 2010

    Report

    Report Number
    2015691-2010-13475
    Event Type
    Death
    Date Received
    June 2, 2010
    Date of Event
    December 24, 2009
    Report Date
    May 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07/14/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), IT WAS LEARNED THAT THE CAUSE OF DEATH WAS VENTRICULAR DYSRUPTION AND ISCHEMIC BOWEL. HOWEVER, THE DEVICE HAS BEEN DISASSOCIATED FROM THE EVENT. THEREFORE, IT HAS BEEN DETERMINED THAT THIS EVENT IS NO LONGER REPORTABLE TO THE FDA.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. TWO REQUESTS WERE MADE (VIA E-MAIL) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION (ON 05/04/2010 AND 05/11/2010); HOWEVER, NO ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.7 MONTHS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    REVISION SURGERY - PT HAD RHEUMATOID ARTHRITIS, GLENOID BAD BONE STOCK.

    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 08A002

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death