BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2002011 · Received February 27, 2011

    Report

    Report Number
    2015691-2011-14925
    Event Type
    Injury
    Date Received
    February 27, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 31, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, DEVICE WAS RECEIVED BY OUR FACILITY FOR ROUTING TO OUR PRODUCT EVAULATION LAB. DEVICE EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE SERIAL NUMBER OF THE REPORTED DEVICE HAS NOT BE PROVIDED; THEREFORE, NO DHR REVIEW CAN BE DONE AT THIS TIME. IF THE DEVICE IS RECEIVED AND UPON COMPLETION OF THE EVALUATION, THE DEVICE WILL BE DISMANTLED FOR THE SERIAL NUMBER. ATTEMPTS ARE BEING MADE FOR RETURN OF THE DEVICE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THE PATIENT. ECHOCARDIOGRAPHY ON DVD HAS BEEN REQUESTED, BUT NOT RECEIVED. OPERATIVE REPORT HAS BEEN REQUESTED, BUT NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY ATTACHED: NO INCONSISTENCIES DETECTED IN THE VALVE RETURNED AS THE LEAFLETS ARE INTACT AND FLEXIBLE, THE WIRE FORM IS INTACT EVIDENT IN THE X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: CONCLUSION: RESEARCH AND DEVELOPMENT CONDUCTED FUNCTIONAL TESTING ON THE RETURNED VALVE AND CONCLUDED WITH THE FOLLOWING: THIS VALVE WAS EXPLANTED AT IMPLANT DUE TO A "MODERATE TO SEVERE TRANSVALVULAR LEAK", WHICH COULD NOT BE REPRODUCED BY EDWARDS' STANDARDIZED IN VITRO TESTING. NO ECHOCARDIOGRAPHY WAS PROVIDED, THUS THE BEHAVIOR OF THE VALVE AND THE LEAKAGE OBSERVED IN VIVO CANNOT BE CONFIRMED. EDWARDS STANDARDIZED IN VITRO TESTING DEMONSTRATES THAT THE FUNCTIONALITY OF THE VALVE IS ACCEPTABLE (B)(4). THE AS-RECEIVED VALVE SHOWED A 6.3% TOTAL REGURGITANT FRACTION (TRF). THIS APPEARS TO BE LARGELY THROUGH A NON-CENTRAL ORIGIN BECAUSE SUBSEQUENT RE-TESTING OF THE VALVE WITH THE SEWING RING SEALED SHOWS THAT THE TRF WAS REDUCED TO 3.1%. THIS VALUE IS MORE THAN THREE TIMES LOWER THAN 10% ALLOWANCE (B)(4) FOR THIS SIZE OF VALVE. CORRECTED DATA: METHOD: (B)(4) X-RAY

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS EXPLANTED AT IMPLANT DUE TO REGURGITATION. THE EVENT WAS LEARNED THROUGH AN EMAIL SENT BY THE HOSPITAL. THE EMAIL STATED "LAST THURSDAY, JANUARY 27TH, [SURGEON] USED THE ABOVE VALVE ON A PATIENT. AFTER THE VALVE WAS IMPLANTED, THERE WAS MODERATE TO SEVERE TRANSVALVULAR LEAK PRESENT. THIS VALVE WAS THEN EXPLANTED AND A NEW ONE, THE SAME MODEL & SIZE, IMPLANTED." THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER, SALES REPRESENTATIVE HAS LEARNED THAT THE PATIENT DID COME OFF PUMP WITHIN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 10K218

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R