BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1862712 · Received October 8, 2010

    Report

    Report Number
    2015691-2010-14186
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 15, 2010
    Report Date
    September 9, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) TOO SMALL OF A ROOT. DEVICE NOT RETURNED. THIS EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, ADDITIONAL INFORMATION AND A COPY OF THE OPERATIVE REPORT WERE RECEIVED. UNFORTUNATELY, THE DEVICE WAS DISCARDED, THEREFORE, IS UNAVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO A SIZING ISSUE. THE SURGEON DISASSOCIATED THE DEVICE FROM THE EVENT, AND PROVIDED "TOO SMALL OF A ROOT" AS THE REASON FOR EXPLANT. THROUGH THE OPERATIVE REPORT, THE FOLLOWING WAS LEARNED: "A 19 MM MAGNA VALVE WAS SIZED AND FELT TO BE ABLE TO FIT. A TOTAL OF SIXTEEN STITCHES WERE PLACED WITH A PLEDGET ON THE VENTRICULAR SIDE, AND THE 19 MM MAGNA WAS PLACED AND SEATED AND TIED DOWN. HOWEVER, UPON TYING DOWN NEAR THE RIGHT CORONARY, THE AORTIC ROOT WAS DEHISCING JUST FROM THE ACTION OF TYING AND BECAUSE OF HOW TIGHT THE VALVE WAS. AT THIS POINT THE DECISION WAS MADE TO BYPASS THE RIGHT CORONARY" A 5 MM AORTOTOMY WAS MADE, AND A 1.5 SHUNT WAS PLACED" ETHIBONDS WERE USED TO GO FROM THE AORTA ON THE RIGHT CORONARY SIDE THROUGH THE CUFF OF THE VALVE, REINFORCING THAT AREA TO KEEP IT FROM DEHISCING. THEN A PATCH WAS USED TO TIE THIS PATCH WITH THESE PLEDGETED STITCHES AND TIE IT DOWN" ONCE WE CLOSED AND THE AORTIC CROSSCLAMP WAS REMOVED AND THE RETROGRADES WERE REMOVED, THE PATIENT HAD A DIFFICULT TIME EJECTING" UPON LOOKING AT THE TEE, WE FELT THAT THE LV FUNCTION WAS SIGNIFICANTLY DECREASED" THE AORTOTOMY WAS REOPENED AT THE PATCH SITE AND NOTED THAT THE AORTIC VALVE WAS STILL TOO TIGHT AND WAS ACTUALLY COMPRESSING THE LEFT MAIN CORONARY"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-09D0820

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention