BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2970483 · Received February 20, 2013

    Report

    Report Number
    2015691-2013-19339
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 22, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REGURGITATION IS CONSIDERED TO BE A PERIVALVULAR LEAK (PVL) IF A TURBULENT ECCENTRIC JET ORIGINATES BETWEEN THE BIOPROSTHETIC SEWING RING AND THE ANNULUS. WHILE THE MAJORITY OF AFFECTED PATIENTS ARE ASYMPTOMATIC, PVL, WHEN SEVERE, CAN LEAD TO SIGNIFICANT MORBIDITY INCLUDING HEART FAILURE AND HEMOLYTIC ANEMIA. THERE MAY BE MULTIPLE CAUSES OF PVL. ANNULAR CALCIFICATION IS A RISK FACTOR FOR THE DEVELOPMENT OF PERI-OPERATIVE PVL AS THE BIOPROSTHESIS MAY NOT SEAT PROPERLY AFTER DEBRIDEMENT. ANATOMICAL FACTORS MAY ALSO CREATE DIFFICULTY SEATING THE BIOPROSTHETIC VALVE RESULTING IN PVL. UNFORTUNATELY, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONFIRMED WITH THE AVAILABLE INFORMATION AND WITHOUT THE SAMPLE DEVICE. REQUESTS FOR ADDITIONAL INFORMATION ARE CURRENTLY BEING MADE. NO FURTHER ACTIONS ARE POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED DUE TO A PARAVALVULAR LEAK AFTER IMPLANT. THE DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE, SAME MODEL AND SIZE. THE EXPLANTED VALVE WAS DISCARDED BY THE HOSPITAL. THE HEALTHCARE PROVIDER ALSO NOTED THAT THERE WAS NO MALFUNCTION OR DEFICIENCY OF THE DEVICE. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74273 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention