BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1013159 · Received March 14, 2008

    Report

    Report Number
    6000002-2008-06212
    Event Type
    Death
    Date Received
    March 14, 2008
    Report Date
    February 20, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD VALVE REPLACEMENT SURGERY IN 2008 AND EXPIRED 51 DAYS LATER DUE TO COMPLICATIONS. REPORTEDLY, THE NEW VALVE LEAKED AND HAD TO BE REPLACED CAUSING EXTENDED SURGERY TIME. THIS INFO WAS REPORTED BY THE PT'S SPOUSE VIA LETTER ON 02/15/08. AN ATTEMPT WAS MADE TO FOLLOW UP WITH THE DECEASED'S SPOUSE ON THE FOLLOWING MONTH; HOWEVER, WE WERE UNABLE TO MAKE CONTACT USING THE TELEPHONE NUMBER PROVIDED ON THE PT'S REGISTRY CARD. FOLLOW UP WITH THE SURGEON'S OFFICE ON THE NEXT DAY, DID NOT INDICATE WHY THE PT EXPIRED, HOWEVER, IT WAS REPORTED THAT THE PT'S INITIAL IMPLANT WAS REPLACED WITH A ST. JUDE DEVICE, HOWEVER, IT WAS OBSERVED THAT THE ST. JUDE DEVICE WAS LEAKING AND HAD TO BE EXPLANTED AND REPLACED WITH EDWARDS, MODEL NUMBER 6900P. A COPY OF THE OP REPORT WAS REQUESTED. HOWEVER, OUR REQUEST WAS DENIED DUE TO HIPPA. IT WAS SUGGESTED THAT THE REPORT BE REQUESTED FROM THE HOSP. FOLLOW UP WITH THE HOSP ON THE NEXT DAY, INDICATED THAT THE OP REPORT CANNOT BE PROVIDED WITHOUT A HIPPA RELEASE FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 6900P31MM 3M2006

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death