BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 3073320 · Received April 23, 2013

    Report

    Report Number
    2015691-2013-19888
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 25, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT YET RECEIVED BY EVALUATION LAB. CONCLUSION: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THE DEVICE IS CURRENTLY EN ROUTE FROM EUROPE TO THE U.S. EVALUATION LAB AND IS ANTICIPATED TO ARRIVE IN MAY. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PRODUCT EVALUATION. THE OPERATIVE REPORT WAS RECEIVED BUT IS NOT IN ENGLISH. IT IS CURRENTLY BEING TRANSLATED. THE INTRA-OPERATIVE ECHOCARDIOGRAPHY HAS NOT BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINT OF REGURGITATION COULD BE CONFIRMED BASED ON VISUAL OBSERVATION. AS RECEIVED, THE LEAFLETS EXHIBIT CHARACTERISTIC MARKINGS WHICH INDICATE SUTURES WERE LOOPED AROUND COMMISSURE 1, AND AROUND COMMISSURE 3. SUTURE TRACK AND PERMANENT INDENTATIONS WERE PRESENT ON THE FREE MARGINS OF LEAFLETS 1 AND 3 AT COMMISSURE 1, AND THE FREE MARGINS OF LEAFLETS 2 AND 3 AT COMMISSURE 3. THESE INDENTATIONS WERE MOST LIKELY LEFT BY SUTURES THAT WERE TIED TIGHTLY DOWN AND AGAINST COMMISSURES 1 AND 3, THUS LEADING TO A GAP AT THE COAPTATION REGION. NO OTHER INCONSISTENCIES WERE VISUALLY NOTED OR IN THE X-RAY, AS THE WIREFORM IS INTACT. METHOD: X-RAY. CONCLUSION: THE EVALUATION CONFIRMS THE CUSTOMER REPORT OF REGURGITATION WITH A ROOT CAUSE OF SUTURE LOOPING AROUND COMMISSURE 1. 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." FOLLOW UP WITH THE SURGEON INCLUDES WRITTEN NOTIFICATION TO THE CUSTOMER.

    Description of Event or Problem · 1

    REPORTEDLY, A 27MM MITRAL VALVE WAS EXPLANTED AFTER IMPLANT DUE TO SEVERE REGURGITATION DETECTED ON ECHO. THE CUSTOMER DESCRIPTION OF EVENT READS: AFTER MITRAL VALVE REPLECEMENT AND RESECTION OF THE SUBAOTIC MEMBRANE, WE DEMONSTRATED A SEVERE MITRAL REGURGITATION IN TEE IN THE OR - WE WENT ON BYPASS AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173433 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 13A006

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R