BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 3782160 · Received April 30, 2014

    Report

    Report Number
    2015691-2014-00991
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    January 22, 2014
    Report Date
    April 1, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STENOTIC AND INSUFFICIENT BIOPROSTHETIC VALVE. ADDITIONAL MANUFACTURER NARRATIVE - THE REPORTED EXPLANTED DEVICE WAS NOT RETURNED TO MANUFACTURER. WITHOUT RETURN OF DEVICE, THE REPORTED STENOSIS AND INSUFFICIENCY CANNOT BE CONFIRMED. THIS PATIENT IS NOTED TO HAVE "BULLOUS PEMPHIGOID" AND DETERIORATION OF DEVICE, WHICH MAY BE RELATED TO SYSTEMIC INFLAMMATION. IT APPEARS THAT PATIENT RELATED FACTORS LIKELY CONTRIBUTED TO THIS EVENT. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION. EDWARDS WILL CONTINUE TO MONITOR ALL EVENTS.

    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 A SECOND DEVICE WAS IMPLANTED IN THE SAME TRICUSPID POSITION USING A VALVE-IN-VALVE PROCEDURE. THE IMPLANT DURATION OF THE ORIGINAL DEVICE AT THE TIME OF THE PROCEDURE WAS APPROXIMATELY 5 YEARS. AS PER FOLLOW UP THE SURGEON ADVISED REGARDING THE CAUSE OF DEGENERATION WAS UNCLEAR, THE PATIENT HAD "BULLOUS PEMPHIGOID", AND PROBABLY THE DEGENERATION WAS RELATED WITH SOME SYSTEMIC INFLAMMATION. THE PATIENT PRESENTED PRIOR SURGERY NYHA III WITH SHORTNESS OF BREATH, IN ADDITION THE VALVE WAS STENOTIC AND INSUFFICIENT. THE PATIENT WAS DISCHARGED FEW DAYS AFTER REOPERATION. NO VALVE AVAILABLE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260059 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R