BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2880053 · Received December 19, 2012

    Report

    Report Number
    2015691-2012-18894
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, METHOD = X-RAY. DEVICE EVALUATION SUMMARY: AS RECEIVED, LEAFLETS 2 AND 3 EXHIBITED CHARACTERISTIC MARKINGS WHICH INDICATE A SUTURE WAS LOOPED AROUND COMMISSURE 3. SUTURE TRACK AND PERMANENT INDENTATIONS WERE PRESENT ON THE FREE MARGINS OF LEAFLETS 2 AND 3 AT COMMISSURE 3. THESE INDENTATIONS WERE MOST LIKELY LEFT BY THE SUTURE THAT WERE TIED TIGHTLY DOWN AND AGAINST COMMISSURE 3, THUS LEADING TO A GAP AT THE COAPTATION REGION. NO OTHER INCONSISTENCIES WERE VISUALLY NOTED OR IN THE X-RAY, AS THE WIREFORM IS INTACT. ADDITIONAL MANUFACTURER NARRATIVE: DEVICE EVALUATION CONFIRMS THAT THE PRIMARY CAUSE OF THE EXHIBITED REGURGITATION LEADING TO THIS EXPLANT IS SUTURE LOOPING. 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. THERE IS NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT AN EDWARDS MITRAL BIOPROSTHETIC VALVE HAS TO BE EXPLANTED AT IMPLANT DUE TO A LARGE CENTRAL LEAK. IT WAS THEN LEARNED THAT THE PATIENT WAS BROUGHT BACK TO THE O.R FOR BLEEDING, WHERE IT WAS OBSERVED THAT THE CENTRAL LEAK WAS SIGNIFICANT. THE VALVE WAS EXPLANTED AND REPLACED WITH A NON-EDWARDS BIOPROSTHESIS. IT WAS ALSO REPORTED THAT THE PATIENT'S HOSPITAL COURSE DID NOT GO AS EXPECTED. NO MEDICAL RECORDS YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 7300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R