BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1905295 · Received November 22, 2010

    Report

    Report Number
    2015691-2010-14421
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED, THE VALVE EXHIBITS A CUT OUT IN THE TISSUE OF LEAFLETS 3. THE SECTION THAT IS MISSING, POSSIBLY FOR PATHOLOGY TESTING, MEASURES TO APPROXIMATELY 2MM AT THE FREE MARGIN BY 8MM INTO THE CUSP AREA. A SUTURE TRACK IS DETECTED AT THE FREE MARGIN OF LEAFLET 1 AND 3 AT COMMISSURE 1. INDENTATIONS IN THE FREE MARGINS ARE TYPICAL TO THOSE MADE BY A SUTURE LOOP. A SUTURE MOST LIKELY LOOPED OVER COMMISSURE 1. A SECOND SUTURE TRACK IS EVIDENT IN THE FREE MARGINS OF LEAFLETS 2 AND 3 WHICH SUGGEST ANOTHER SUTURE MOST LIKELY LOOPED OVER COMMISSURE 3 AS WELL. NO INCONSISTENCIES DETECTED OR IN THE X-RAY. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. CONCLUSION: 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

    AN EVENT WAS REPORTED TO OUR SALES REP THAT A VALVE WAS EXPLANTED AT IMPLANT FOR UNKNOWN REASONS AND REPLACED BY THE SAME MODEL, SMALLER SIZE DEVICE. THE REASON FOR EXPLANT WAS NOT PROVIDED AND NO PATIENT INFORMATION WAS DISCLOSED.

    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-9A0034

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R