BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3260333 · Received August 1, 2013

    Report

    Report Number
    2015691-2013-20719
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    May 22, 2013
    Report Date
    July 3, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. PVL CAN OCCUR IN THE MITRAL AND AORTIC POSITION FOR SIMILAR REASONS. 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 CREATE DIFFICULTY SEATING THE BIOPROSTHETIC VALVE RESULTING IN PVL. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS IMPLANTED THEN EXPLANTED DURING THE SAME PROCEDURE. PER THE OP REPORT, THE PATIENT HAD SEVERE NATIVE AORTIC VALVE STENOSIS WITH SEVERE CALCIFICATION REQUIRING AORTIC VALVE REPLACEMENT WITH THE EDWARDS VALVE. UPON COMING OFF BYPASS, THE VALVE WAS INSPECTED AND THERE WAS NOTED TO BE A PERIVALVULAR LEAK (PVL). PATIENT WAS PLACED BACK ON CARDIOPULMONARY BYPASS AND THERE WAS POOR COAPTATION OF THE ANNULAR TISSUE ALONG THE POSTERIOR PORTION OF THE VALVE POSTERIOR TO THE LEFT CORONARY ARTERY. SUTURES WERE PLACED TO CORRECT THE DEFECT. AFTER COMING OFF BYPASS AGAIN, A SIGNIFICANT PVL WAS STILL NOTED AT THE SAME LOCATION. THEREFORE, THE DEVICE WAS REMOVED AND A NEW 25 MM VALVE WAS IMPLANTED. THIS TIME THERE WAS NO PVL ON TRANSESOPHAGEAL ECHOCARDIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360942 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-11F2196

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention