BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2895873 · Received January 3, 2013

    Report

    Report Number
    2015691-2013-19002
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 7, 2012
    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

    THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROGRESS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED BY THE HOSPITAL. THROUGH FOLLOW UP WITH THE SURGEON, NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE. PARAVALVULAR LEAK (PVL) REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE, AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE. THE MOST COMMON REASON FOR PVL IS INADEQUATE DEBRIDEMENT OF A CALCIFIED ANNULUS AND IS NOT A RESULT OF DEVICE MALFUNCTION. IN THIS CASE, THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 12 DAYS. THE CUSTOMER WAS ASKED AND HAS AFFIRMED THAT THERE WAS NO MALFUNCTION OF THE DEVICE BUT HAS NOT PROVIDED ANY ADDITIONAL INFORMATION TO EXPLAIN HIS REPORT OF PARAVALVULAR LEAK. WITHOUT ADDITIONAL INFORMATION, WE ARE UNABLE TO DETERMINE ROOT CAUSE FOR EXPLANT OF THIS DEVICE.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, A 23 MM VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 12 DAYS DUE TO PARAVALVULAR LEAKAGE (PVL). ON (B)(6) 2012, A MAGNA EASE VALVE, MODEL 3300 TF X 23 MM, WAS IMPLANTED. INITIAL INFORMATION WAS LEARNED THROUGH (B)(6) IMPLANT PATIENT REGISTRY. THROUGH FOLLOW UP, IT WAS LEARNED THE CUSTOMER DECIDED TO PERFORM RE-AVR TO CORRECT PVL ON (B)(6) 2012. THE VALVE WAS EXPLANTED AND REPLACED WITH A MAGNA EASE VALVE, MODEL 3300 TF X 23 MM. THE CUSTOMER WAS ASKED AND HAS AFFIRMED THAT THERE WAS NO MALFUNCTION OF THE DEVICE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX23MM 12A009

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R