BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT® MAGNA MITRAL EASE¿ PERICARDIAL BIOPROSTHESES

    MDR report key: 2130936 · Received June 16, 2011

    Report

    Report Number
    2015691-2011-15724
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - SUTURE LOOP. EVALUATION METHOD: DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. THE DEVICE HAS BEEN REQUESTED TO RETURN FOR ANALYSIS. CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    REMOVE DATA REPORTED ON INITIAL MDR. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. ALTHOUGH, THERE WAS NO PRODUCT TO EVALUATE, IT APPEARS THAT THE EVENT WAS DUE TO SUTURE LOOPING AS INDICATED IN THE OPERATIVE REPORT. SUTURE LOOPS OCCUR WHEN A SUTURE IS CAUGHT ON THE STENT POST OR COMMISSURE AND PREVENTS THE LEAFLETS OF A BIOPROSTHETIC HEART VALVE FROM FUNCTIONING PROPERLY. THIS OCCURS DUE TO IMPROPER TECHNIQUE OR POOR VISUALIZATION OF THE VALVE DURING IMPLANTATION, AND IS NOT A MALFUNCTION OF THE DEVICE. IN MILD CASES, IT MAY GO UNDETECTED AND MAY CAUSE MILD REGURGITATION. IN OTHER CASES, SEVERE REGURGITATION MAY RESULT WHICH MAY BE DETECTED DURING THE PROCEDURE OR AT SOME LATER TIME DURING THE POST-OPERATIVE PERIOD, WHICH MAY REQUIRE REOPERATION. EDWARDS' VALVES HAVE A SPECIALIZED HOLDER DESIGNED TO PREVENT OR MINIMIZE SUTURE LOOPING. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING CAUTION STATEMENT: CAUTION: AVOID LOOPING OR CATCHING A SUTURE AROUND THE OPEN CAGES, FREE STRUTS OR COMMISSURE SUPPORTS OF THE VALVE WHICH WOULD INTERFERE WITH PROPER VALVULAR FUNCTION. THE IFU FURTHER INSTRUCTS THE SURGEON ON HOW TO AVOID SUTURE LOOPING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EDWARDS VALVE WAS EXPLANTED AT IMPLANT. THE SURGEON ATTEMPTED A ROBOTIC MITRAL VALVE REPAIR OF THE PATIENT'S NATIVE VALVE USING A NON-EDWARDS RING. THIS RESULTED IN AN UNSUCCESSFUL RING REPAIR. THIS RING WAS EXPLANTED AND AN EDWARDS 7300TFX VALVE WAS IMPLANTED. THE SURGEON INDICATED THE VALVE WAS DEFECTIVE, POSSIBLY DUE TO A "POSTERIOR LEAFLET OF THE VALVE THAT DID NOT MOVE". PER THE OPERATIVE REPORT, "WE WERE PREPARING TO COME OFF CARDIOPULMONARY BYPASS, WHEN ANESTHESIA NOTED THAT THERE WAS MITRAL INSUFFICIENCY. THIS INSUFFICIENCY, HOWEVER, WAS NOT PERIVALVULAR BUT WAS INSTEAD INTRAVALVULAR AND APPEARED POSSIBLY BE RELATED T DEFORMATION OF ONE OF THE LEAFLETS. WE REOPENED THE ATRIAL INCISION AND REMOVED ALL THE SUTURES, INCLUDING THE PLEDGETS, AND IT DID APPEAR THAT ONE OF THE PLEDGETS OR SUTURES HAS PERHAPS DEFORMED ONE OF THE STRUTS AROUND 7 O'CLOCK NEAR THE POSTERIOR LEAFLET. WE SELECTED ANOTHER 27 PERICARDIAL VALVE, BUT BY THIS POINT THE PATIENT HAD BEEN ON BYPASS FOR QUITE SOME TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT® MAGNA MITRAL EASE¿ PERICARDIAL BIOPROSTHESES REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX R-11B0421

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R