BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3021875 · Received March 26, 2013

    Report

    Report Number
    2015691-2013-19660
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    November 22, 2012
    Report Date
    February 26, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED. HOWEVER, THE SURGEON HAS INDICATED THAT THIS EVENT WAS NOT DEVICE RELATED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 4 MONTHS DUE TO PROSTHETIC VALVE ENDOCARDITIS. UNFORTUNATELY, THE INFECTION SOURCE IS UNKNOWN; HOWEVER, THE SURGEON HAS INDICATED THAT THIS EVENT WAS NOT DEVICE RELATED. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124075 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX S-12E1697

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R