BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2131324 · Received June 16, 2011

    Report

    Report Number
    2015691-2011-15726
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    November 28, 2010
    Report Date
    May 19, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. PER THE RECEIVED OPERATIVE REPORT, THIS INCIDENT IS A RESULT OF A SUTURE LOOP AND A STITCH TEARING THROUGH THE PATIENT'S ANNULUS. 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. THE INVESTIGATION REVEALS NOTHING TO INDICATE A DEVICE MALFUNCTION OR QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    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 THAT THE EDWARDS' VALVE WAS EXPLANTED AT IMPLANT, AND REPLACED WITH ANOTHER SAME MODEL AND SIZE PROSTHESIS. THROUGH FOLLOW-UP, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED DUE TO SLUGGISH HEMODYNAMICS, SPECIFICALLY MITRAL REGURGITATION. OPERATIVE REPORT INDICATES," WE CAME OFF PUMP. THE PATIENT'S HEMODYNAMICS WERE SLUGGISH...PATIENT HAD SIGNIFICANT MITRAL REGURGITATION...WENT BACK ON PUMP...REINSPECTED THE VALVE, ONE OF THE VALVE STITCHES FROM THE POSTERIOR ANNULUS HAD TORN THROUGH. IN ADDITION, THERE APPEARED TO BE AN ENTRAPMENT OF ONE OF THE POSTS OF THE VALVE WITH THE SUTURE LINE WHICH WAS A SEPARATE SUTURE FROM THE ONE THAT HAD PULLED THROUGH. REMOVED ALL OF THE PLEDGETS AND THE VALVE, AND GOT ANOTHER 27 PERIMOUNT VALVE AND REPEATED THE PROCESS OF PLACING A VALVE SUTURE CIRCUMFERENTIALLY. THIS TIME I USED AN EVERTING TECHNIQUE WITH THE PLEDGETS ON THE ATRIAL SIDE OF THE ANNULUS". THE SURGEON INDICATED THAT THE REASON FOR THIS EXPLANT IS PROCEDURE RELATED AND NOT DUE TO A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P R-08E0943

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention