BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 1903947 · Received November 20, 2010

    Report

    Report Number
    2015691-2010-14411
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    August 12, 2010
    Report Date
    October 22, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = SUTURE LOOP.DEVICE NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    PATIENT AND/OR DEVICE STATUS IS REPORTED TO THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS. ON 11/19/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH-CARE PROVIDER. IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO A SUTURE LOOP AND PERIVALVULAR LEAK. IT WAS ALSO NOTED THAT THE PATIENT HAD ENDOCARDITIS. PER THE SURGEON, THE REASON FOR EXPLANTING THE DEVICE WAS NOT RELATED TO A DEVICE MALFUNCTION, BUT PROCEDURE RELATED. THE OPERATIVE REPORT WAS REQUESTED, BUT WAS NOT PROVIDED. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX R-10A0126

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention