BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3800999 · Received May 8, 2014

    Report

    Report Number
    2015691-2014-01065
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 4, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: X-RAY. EVALUATION SUMMARY: THE EXPLANTED DEVICE WAS RETURNED AND EVALUATED; AS RECEIVED, THE LEAFLETS EXHIBITED CHARACTERISTIC MARKINGS WHICH INDICATE A SUTURE WAS LOOPED AROUND COMMISSURE 2. SUTURE TRACK AND PERMANENT INDENTATIONS WERE PRESENT ON THE FREE MARGINS OF LEAFLETS 1 AND 2 AT COMMISSURE 2. THESE INDENTATIONS WERE MOST LIKELY LEFT BY A SUTURE THAT WAS TIED TIGHTLY DOWN AND AGAINST COMMISSURE 2. THE WIREFORM WAS INTACT, AS EVIDENT IN THE X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: DEVICE EVALUATION CONFIRMS SUTURE LOOPING AS THE ROOT CAUSE OF THE REPORTED REGURGITATION AND LEAFLET MALCOAPTATION LEADING TO THIS EVENT. 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. IN THIS CASE, EDWARDS INVESTIGATION REVEALS THAT THE TRICENTRIX HOLDER WAS LIKELY NOT DEPLOYED PER THE PROVIDED INSTRUCTIONS WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE CUSTOMER HAS BEEN RETRAINED ON THE PROPER USE AND DEPLOYMENT OF THE TRICENTRIX HOLDER. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THERE IS NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EDWARDS MITRAL BIOPROSTHETIC VALVE WAS EXPLANTED AT IMPLANT DUE TO "DEFECTIVE LEAFLETS." REPORT INDICATES THAT THE PATIENT EXHIBITED SEVERE MITRAL REGURGITATION WHEN COMING OFF BYPASS. SURGEON NOTED THAT TWO OF THE LEAFLETS NEAR ONE STENT POST HAD AN "INDENTATION" AND WERE NOT COAPTING PROPERLY, TYPICAL OF A LOOPED SUTURE. PER CONVERSATION WITH THE SURGEON, IT WAS CONFIRMED THAT THIS WAS A SUTURE LOOP, AND THAT THE EDWARDS TRICENTRIX HOLDER WAS NOT DEPLOYED PROPERLY. THE VALVE WAS REPLACED WITH ANOTHER SAME MODEL/SIZE DEVICE WITH NO FURTHER COMPLICATIONS. THE PATIENT WAS DISCHARGED AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277670 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX R-12G2569

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R