BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2884722 · Received December 26, 2012

    Report

    Report Number
    2015691-2012-18953
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY ATTACHED: AS RECEIVED, THE LEAFLETS EXHIBITED CHARACTERISTIC MARKINGS WHICH INDICATE SUTURES WERE LOOPED AROUND COMMISSURE 1, AND AROUND COMMISSURE 3. LEAFLETS 1 AND 3 APPEARED BENT TOWARDS LEAFLET 1. SUTURE TRACK AND PERMANENT INDENTATIONS WERE PRESENT ON THE FREE MARGINS OF LEAFLETS 1 AND 3 AT COMMISSURE 1, AND THE FREE MARGIN OF LEAFLET 3 AT COMMISSURE 3. THESE INDENTATIONS WERE MOST LIKELY LEFT BY SUTURES THAT WERE TIED TIGHTLY DOWN AND AGAINST COMMISSURE 1 AND 3. SEWING RING WAS ALSO TORN AT COMMISSURE 1 AT THE INFLOW ASPECT. NO VISIBLE CALCIFICATION WAS OBSERVED. NO INCONSISTENCIES DETECTED IN THE X-RAY AS THE WIREFORM WAS INTACT X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. 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.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. CONCLUSION: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. REPORTEDLY, A 27MM MITRAL VALVE WAS EXPLANTED AFTER AN UNKNOWN IMPLANT PERIOD. IMPLANT AND EXPLANT DATES HAVE NOT BEEN REPORTED. NO DOCUMENTS PROVIDED. NO PATIENT HISTORY PROVIDED. THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROGRESS. THE DEVICE WAS RECEIVED AT OUR FACILITY IN SWITZERLAND FOR PROCESSING AND SHIPMENT TO THE U.S. FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PERIMOUNT VALVE DID NOT OPEN FULLY AFTER IMPLANTATION. PER THE CUSTOMER LETTER: ANTEROLATERAL COMMISSURE STRUT WAS NOT SEATING BELOW THE ANNULUS, HENCE SUTURE WERE CUT AND SUTURES WERE RE-TAKEN TO SETA THE VALVE INTO THE ANNULUS. NO FORCE USED. THE THREE STRUTS WERE ALL BELOW THE ANNULUS AND WELL SEATED, BUT THE VALVE WAS IN AN INCOMPETENT POSITION. SUTURES WERE CONFIRMED TO BE WELL OUT OF THE WAY OF THE STRUTS. LATER ON WHEN VALVE WAS EXPLANTED, I COULD ONLY EXPLAIN THE INCOMPETENCE DUE TO STRETCHING APART OF THE STRUTS BETWEEN ANTEROLATERAL AND POSTERIOR COMMISSURE. LOT OF AORTIC CROSS CLAMP TIME AND CARE WAS TAKEN TO SETA THIS VALVE WITH THE UTMOST GENTLENESS TO AVOID DAMAGE TO LEAFLET MECHANISM.

    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 12G214

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R