BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS

    MDR report key: 1920200 · Received December 10, 2010

    Report

    Report Number
    2015691-2010-14512
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 12, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P010041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. DEVICE IS TO BE RETURNED FOR EVALUATION. INVESTIGATION IS ON-GOING.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE VALVE WAS OBSERVED VISUALLY AND WITH A LIGHT MICROSCOPE. NO INCONSISTENCIES DETECTED AS THE LEAFLETS ARE INTACT AND FLEXIBLE AND THE WIREFORM IS INTACT, EVIDENT IN THE X-RAY. THE VALVE WAS SENT TO RESEARCH AND DEVELOPMENT FOR FUNCTIONAL TESTING. THE SERIAL TAG AND THE HOLDER ARE ALSO RECEIVED. 020/8/11 R&D RESULTS: SUMMARY AND CONCLUSIONS: THIS VALVE WAS REPORTEDLY EXPLANTED AT IMPLANT DUE TO A LEFT VENTRICULAR BLOCK AND VALVE REGURGITATION. SINCE NO ECHO WAS PROVIDED, THE BEHAVIOR OF THE VALVE IN VIVO CANNOT BE CONFIRMED. EDWARDS STANDARDIZED IN VITRO TESTING SHOWS THE FUNCTIONALITY OF THE VALVE IS ACCEPTABLE PER ISO5840:2005. THE SMALL AMOUNT OF NON-CENTRAL LEAKAGE (2.3%) DETECTED IS MORE THAN 4 TIMES LOWER THAN THE 10% MAXIMUM ALLOWED PER ISO5840:2005. METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: WE RECEIVED A RESPONSE FROM THE CUSTOMER REGARDING OUR REQUEST FOR A COPY OF THE TEE. THE RESPONSE PROVIDED WAS "DID NOT HAVE ULTRASOUND REPORT DURING THE SURGERY".

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A DEVICE WAS EXPLANTED AT IMPLANT DUE TO LEFT VENTRICULAR BLOCK. PER THE CUSTOMER REPORT: "ON (B)(6) 2010, (B)(6) PATIENT, ACCEPTED AORTIC VALVE REPLACEMENT WITH A SIZE 21MM ... SUPRA-ANNULAR PORCINE BIOPROSTHESIS AND 12 INTERMITTENT STITCHES BY HORIZONTAL MATTRESS SUTURE USING ... 2-0 VALVE REPLACEMENT THREADS. THE SURGICAL SUTURE WAS COMPLETED WITHOUT ANY PROBLEMS. AFTER THE ASCENDING AORTA WAS OPENED, THE LEFT VENTRICLE QUICKLY EXPANDED; THE ASCENDING AORTA WAS SUTURED AND OPENED AGAIN, EXPANSION OF LEFT VENTRICLE RECURRED. THE ASCENDING AORTA WAS BLOCKED UP AGAIN. THE BIOPROSTHESIS WAS DISMOUNTED; VALVE REGURGITATION WAS FOUND FOLLOWING WATER FLUSHES. A ... BI-LEAFLET MECHANICAL VALVE WAS SWITCHED TO (THEN IMPLANTED). THE ASCENDING AORTA WAS OPENED, AND THEN THE HEART BEATING RECOVERED AND ENLARGEMENT OF LEFT VENTRICLE DID NOT OCCUR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2650 09L305

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R