BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 4252342 · Received November 14, 2014

    Report

    Report Number
    2015691-2014-02714
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 15, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION BECAUSE IT REMAINS IMPLANTED AFTER A VALVE-IN-VALVE PROCEDURE. HOWEVER, THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. ALTHOUGH BIOPROSTHETIC VALVES HAVE BEEN PROVEN TO HAVE EXCELLENT LONG TERM DURABILITY, FAILURE DOES OCCUR IN A SMALL NUMBER OF VALVES. FAILURE OF A BIOPROSTHETIC VALVE OVER TIME IS MORE LIKELY DUE TO ENDOCARDITIS OR STRUCTURAL VALVE DETERIORATION (SVD) WHICH OCCURS AS A RESULT OF STENOSIS (FROM CALCIFICATION OR HOST TISSUE OVERGROWTH), DEHISCENCE, FIBROSIS OR NON-CALCIFIC DEGENERATION. IN THIS CASE, INFORMATION REGARDING THE VALVE-IN-VALVE PROCEDURE WAS RECEIVED THROUGH OUR IMPLANT PATIENT REGISTRY PROCESS AND SUBSEQUENT ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE CONDITION OF THE DEVICE AT THE TIME OF THE PROCEDURE, PATIENT'S CONDITION POST-IMPLANT OR POSSIBLE COMORBIDITIES WERE UNSUCCESSFUL; THEREFORE, THE ROOT CAUSE FOR THE PROCEDURE REMAINS INDETERMINABLE. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    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, EDWARDS LEARNED THROUGH ITS IMPLANT PATIENT REGISTRY THAT A SECOND DEVICE WAS IMPLANTED IN THE AORTIC POSITION USING A VALVE-IN-VALVE PROCEDURE. THIS WAS TO CORRECT A 21MM AORTIC PERICARDIAL VALVE THAT WAS FAILING. THE IMPLANT DURATION OF THE ORIGINAL DEVICE AT THE TIME OF THE PROCEDURE WAS APPROXIMATELY NINE (9) YEARS AND TEN (10) MONTHS. THE REASON FOR REOPERATION IS UNKNOWN AND BOTH DEVICES REMAIN IMPLANTED. NO ADDITIONAL DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736147 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R