BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 3222792 · Received July 12, 2013

    Report

    Report Number
    2015691-2013-20578
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 13, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. IN THIS CASE, DURING PLACEMENT OF A MITRAL VALVE, THE SURGEON DISTORTED THE AORTIC ROOT WHICH REQUIRED A SUBSEQUENT AORTIC VALVE REPLACEMENT. NO EVALUATION WILL BE PERFORMED SINCE THE SUBJECT DEVICE IS STILL IMPLANTED TO THE PATIENT. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION OR QUALITY DEFICIENCY. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION. RELATED TO MEDWATCH NUMBER: 2015691-2013-20467.

    Description of Event or Problem · 1

    AFTER RE-IMPLANTING THE SUBJECT DEVICE, TEE NOW SHOWS A GOOD RESULT OVER THE MITRAL VALVE. HOWEVER, A HIGH-GRADE AORTAL INSUFFICIENCY THAT WAS NOT PRESENT PREOPERATIVELY WAS PRESENTED, WHICH IS WHY ANOTHER ISCHEMIA PHASE OCCURS WITH OPENING OF THE AORTA ABOVE THE CORONARY OUTFLOWS FOR INSPECTION OF THE AORTIC VALVE. IT EMERGED HERE THAT THE DEEP SUTURES IN THE REGION OF THE ANTERIOR MITRAL VALVE RING DISTORT THE GEOMETRY OF THE CORONARY POCKET OF THE AORTIC VALVE AND CAUSES THE CORONARY POCKET TO STAND OPEN. THIS PROBLEM CANNOT BE REMEDIED WITHOUT OPENING THE FELT SUTURES TO THE MITRAL VALVE, WHICH IS WHY THE DECISION FOR BIOLOGICAL REPLACEMENT OF THE AORTIC VALVE IS TAKEN. AN EDWARDS MAGNA EASE BIOPROSTHESIS VALVE WAS IMPLANTED IN THE AORTIC POSITION. THE FINAL TEE THEN SHOWS A REGULAR FUNCTION OF BOTH EDWARDS BIOPROSTHETIC VALVES, WITH NO INDICATION OF PARAVALVULAR LEAKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322131 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 12F172

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention