BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3002803 · Received March 13, 2013

    Report

    Report Number
    2015691-2013-19533
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PARAVALVULAR LEAK. METHOD: DEVICE NOT RETURNED. THE DEVICE WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED AT THE HOSPITAL. THROUGH FOLLOW UP WITH THE SURGEON, THE PATIENT CONDITION WAS REPORTED AS 'UNDER TREATMENT' AS OF (B)(6) 2012. THERE HAS BEEN NO UPDATE PROVIDED ON THE PATIENT STATUS. THE CUSTOMER COMMENTED THAT THIS EXPLANT WAS NOT EXPECTED AND DISASSOCIATED THE DEVICE FROM THE EVENT. ECHO REPORT WILL NOT BE PROVIDED. CONCLUSION: THE SURGEON INDICATED THIS 19MM DEVICE WAS EXPLANTED DUE TO PARAVALVULAR LEAK AND WAS REPLACED WITH A 16MM VALVE. A PARAVALVULAR LEAK IS DESCRIBED AS A LEAK OUTSIDE THE VALVE, NOT GOING THROUGH THE LEAFLETS, AND REPRESENTS REGURGITANT FLOW BETWEEN THE SEWING RING AND THE AORTIC WALL. IF HEMODYNAMICALLY SIGNIFICANT, THIS WILL REQUIRE REPLACEMENT OF THE HEART VALVE. THERE ARE SEVERAL CONTRIBUTING FACTORS TO A PARAVALVULAR LEAK, INCLUDING BUT NOT LIMITED TO, INSUFFICIENT DEBRIDEMENT OF CALCIFIED TISSUE, SURGICAL TECHNIQUE, AND PATIENT FACTORS (FRAGILE TISSUE). IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THE REPORTED PARAVALVULAR LEAK BUT THE EXPLANT OF THE 19MM DEVICE WITH REPLACEMENT BY A 16MM DEVICE STRONGLY SUGGESTS THAT THIS WAS A SIZING ISSUE AND WAS NOT A MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    REPORTEDLY, A 19 MM VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 16 DAYS DUE TO PARAVALVULAR LEAKAGE. THE CUSTOMER REPORTED THAT A MAGNA EASE VALVE, MODEL 3300TFX19MM, WAS IMPLANTED FOR AORTIC VALVE REPLACEMENT (AVR) WITH ONE-KNOT TECHNIQUE TO CORRECT AORTIC STENOSIS (AS) ON (B)(6) 2013. AFTER A PERIOD OF TIME, PARAVALVULAR LEAKAGE WAS OBSERVED. ON (B)(6) 2013, THE VALVE WAS EXPLANTED AND REPLACED WITH A 16MM VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105079 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3300TFC

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R