BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1973195 · Received January 28, 2011

    Report

    Report Number
    2015691-2011-14721
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    August 24, 2010
    Report Date
    December 29, 2010
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE:THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCES.

    Additional Manufacturer Narrative · 1

    THE DEVICE MODEL AND SERIAL NUMBER WAS NOT PROVIDED. ONLY INFORMATION PROVIDED WAS THAT IT WAS A "#29 CARPENTIER-EDWARDS PERICARDIAL VALVE". (B)(4) LEAFLET DISRUPTION DUE TO SUTURE LOOPING. DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) CANNOT BE INITIATED, AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. 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

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS LEARNED THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER THAT THE DEVICE WAS EXPLANTED AT IMPLANT DUE TO A SUTURE LOOP THAT WAS CAUSING MITRAL REGURGITATION. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT WAS FOUND TO HAVE SEVERE MITRAL REGURGITATION AND WAS REFERRED FOR MITRAL VALVE REPLACEMENT. AFTER THE VALVE WAS PLACED, SEVERE MITRAL REGURGITATION WAS FOUND ON TRANSESOPHAGEAL ECHOCARDIOGRAM. AFTER COMING OFF CARDIOPULMONARY BYPASS AND UPON CHECKING THE MITRAL VALVE PROTHESIS, IT APPEARED THAT THERE WAS A SIGNIFICANT AMOUNT OF MITRAL REGURGITATION AND ON OF THE LEAFLETS APPEARED TO BE SOMEHOW WITH POOR MOBILITY. BECAUSE OF THIS, THE PATIENT'S HEART WAS STOPPED AGAIN AND THE VALVE WAS RE-REPLACED. UPON EXAMINING THE VALVE, IT APPEARED THAT ONE OF THE SUTURES HAD GONE AROUND THE STRUT OF THE MITRAL VALVE CAUSING THE REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE 6900PTFX R-08K2182

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention