BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS

    MDR report key: 2060230 · Received April 15, 2011

    Report

    Report Number
    2015691-2011-15237
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    September 3, 2010
    Report Date
    March 17, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PARAVALVULAR LEAK. DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    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 DEVICE WAS EXPLANTED ON THE SAME DAY OF SURGERY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE OPERATIVE REPORT WAS RECEIVED. ACCORDING TO THE REPORT, THE PATIENT PRESENTED WITH SEVERE SYMPTOMATIC AORTIC STENOSIS. THEREFORE, THE PATIENT WAS REFERRED FOR AORTIC VALVE REPLACEMENT. THE PATIENT'S NATIVE AORTIC VALVE WAS FOUND TO BE SEVERELY CALCIFIED AND BICUSPID. THE EDWARDS VALVE WAS IMPLANTED WHEN A PARAVALVULAR LEAK ALONG THE ANTERIOR OF THE AORTIC VALVE ANNULUS IN THE AREA OF THE MOST SEVERE CALCIFICATIONS WAS NOTED UPON WEANING THE PATIENT OFF CARDIOPULMONARY BYPASS (CPB). THEREFORE, CPB WAS RE-ESTABLISHED AND THE VALVE WAS REMOVED. ADDITIONAL DEBRIDEMENT OF THE EXTENSIVE CALCIFICATIONS WAS PERFORMED AND ANOTHER EDWARDS VALVE OF THE SAME MODEL AND SIZE WAS IMPLANTED. THE PATIENT WAS ONCE AGAIN WEANED FROM CPB WITH A NORMAL FUNCTIONING AORTIC VALVE PROSTHESIS. FURTHERMORE, THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2700 R-10F1442

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention