BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1082106 · Received July 24, 2008

    Report

    Report Number
    6000002-2008-08163
    Event Type
    Death
    Date Received
    July 24, 2008
    Date of Event
    May 2, 2007
    Report Date
    January 3, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. REPORTEDLY, AT THE TIME OF IMPLANTATION OF THE DEVICE, THE PT HAD TRICUSPID VALVE REPAIR INVOLVING A MODEL 4900 28MM THAT WAS EXPLANTED IN 2008. THE REASON FOR THE EXPLANT IS UNK; HOWEVER, IT WAS REPLACED WITH A ANOTHER DEVICE. PLEASE REFER TO MEDWATCH NUMBERS 6000002-2008-08166 AND 6000002-2008-08170.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED IN 2007, APPROX 1 DAY POST-OP DUE TO UNK REASONS. NO OTHER DETAILS WERE PROVIDED. AT THE TIME OF THE PT DEMISE THE PT HAD ANOTHER DEVICE IMPLANTED IN THE TRICUSPID POSITION. PLEASE REFER TO MEDWATCH NUMBER 6000002-2008-08170. THIS PT ADDITIONALLY HAD RING REPAIR ON THE TRICUSPID VALVE. THE RING WAS EXPLANTED AND REPLACED WITH ANOTHER RING. PLEASE REFER TO MEDWATCH NUMBER 6000002-2008-08166. IT APPEARS THAT RING REPAIR WAS ATTEMPTED ON THE TRICUSPID VALVE ON THE SAME DAY OF THE IMPLANT, AND WAS EXPLANTED. TWO FOLLOW UP ATTEMPTS WERE MADE OBTAIN ADD'L INFO CONCERNING THE REPORTED EVENT. NO OTHER INFO WAS FORTHCOMING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death