BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2954738 · Received February 11, 2013

    Report

    Report Number
    2015691-2013-19245
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 15, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REPORT OF DEVICE EXPLANTED AT IMPLANT DUE TO REGURGITATION, CANNOT BE CONFIRMED BASED ON VISUAL OBSERVATION. TWO MINOR NICKS WERE OBSERVED ON LEAFLET 1. BOTH NICKS WERE APPROXIMATELY 1MM IN LENGTH. SERRATED MARKINGS WERE ALSO OBSERVED ON LEAFLET 3. THE WIREFORM WAS INTACT, AS EVIDENT IN THE X-RAY. METHOD: X-RAY. THE VALVE WILL BE SENT TO RESEARCH AND DEVELOPMENT FOR FUNCTIONAL TESTING.

    Additional Manufacturer Narrative · 1

    RESEARCH AND DEVELOPMENT CONCLUDED ITS TESTING AND THE SUMMARY AND CONCLUSION STATES: THIS VALVE WAS EXPLANTED AT IMPLANT DUE TO AORTIC REGURGITATION THAT WAS OBSERVED DURING TRANSESOPHAGEAL ECHOCARDIOGRAPHY. NO ECHOCARDIOGRAPHY RECORDING WAS PROVIDED, THUS THE REPORTED BEHAVIOR AND FUNCTIONALITY OF THE BIOPROSTHETIC VALVE IN VIVO CANNOT BE CONFIRMED. TRANSIENT NON-CENTRAL LEAK THROUGH THE SEWING RING AND STENT SUBASSEMBLY AREAS IS TYPICAL FOR THIS TYPE OF BIOPROSTHESIS INITIALLY AT IMPLANT, AND SHOULD BE REDUCED TO A NEGLIGIBLE LEVEL SHORTLY AFTER THE REVERSAL OF HEPARIN WITH PROTAMINE IN THE LATER STAGES OF THE OPERATION. THE REPORTED 'ONE OF THE LEAFLETS WAS LEAKING' COULD NOT BE REPRODUCED BY THE IN VITRO TESTING. EDWARDS' STANDARDIZED IN VITRO TESTING DEMONSTRATES THAT THE FUNCTIONALITY OF THE VALVE IS ACCEPTABLE PER ISO5840:2005. THE UNSEALED AS RECEIVED VALVE SHOWED AN 6.4 % TOTAL REGURGITANT FRACTION (TRF), WHICH 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 1.6%. THIS VALUE IS MORE THAN NINE TIMES LOWER THAN 15% ALLOWANCE PER ISO5840:2005 FOR THIS SIZE OF VALVE.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROGRESS. DEVICE IS REPORTEDLY AVAILABLE FOR RETURN BUT HAS NOT BEEN RECEIVED. NO PATIENT INFORMATION WAS MADE AVAILABLE IN THE INITIAL REPORT AND HAS NOT BEEN PROVIDED IN FOLLOW UPS WITH THE HEALTH CARE PROVIDER.

    Description of Event or Problem · 1

    REPORTEDLY, A 25MM AORTIC VALVE WAS IMPLANTED ON (B)(6) 2013. AFTER THE CASE, THEY ASSESSED THE VALVE WITH TEE. THEY NOTED THAT ONE LEAFLET WAS LEAKING AND NEEDED TO GO BACK ON BYPASS TO CHANGE THE VALVE. A 23MM PERIMOUNT MAGNA EASE VALVE WAS IMPLANTED INSTEAD. NO LEAK WAS SEEN FOLLOWING THE SECOND IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59090 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R