BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES

    MDR report key: 2891646 · Received December 31, 2012

    Report

    Report Number
    2015691-2012-18980
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    October 31, 2012
    Report Date
    December 3, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANTS AT IMPLANT ARE TYPICALLY A RESULT OF INAPPROPRIATE SIZING, DISTORTION OF THE VALVE DURING IMPLANTATION AND/OR THE PATIENT'S ANATOMY, AND NOT A MALFUNCTION OF THE DEVICE. AFTER A VALVE IS IMPLANTED, THE PATIENT IS WEANED FROM CARDIOPULMONARY BYPASS (CPB). FIRST, THE HEART IS WARMED AND ALLOWED TO SPONTANEOUSLY BEAT. THEN, THE HEART IS ALLOWED TO FILL GRADUALLY AS CPB IS DECREASED. DURING THIS TIME A TEE IS ROUTINELY PERFORMED TO CHECK VALVE FUNCTION. IF THE VALVE IS FUNCTIONING NORMALLY, BYPASS WILL BE DISCONTINUED AND THE AORTIC/VENOUS CANNULAE ARE REMOVED. THERE MAY BE CASES IN WHICH REGURGITATION IS DETECTED BY TEE PRIOR TO THE COMPLETE DISCONTINUATION OF CPB AND REMOVAL OF CANNULAE. IF THERE IS EVIDENCE OF INTERVENTION REQUIRED AFTER COMPLETE DISCONTINUATION OF CPB AND REMOVAL OF CANNULAE (FOR EXAMPLE LEAFLET NOT COAPTING), THIS MAY REQUIRE SIGNIFICANTLY EXTENDED OPERATIVE AND CARDIOPULMONARY BYPASS TIME, WHICH INCREASES THE RISK OF THE PROCEDURE. THROUGH FOLLOW UP WITH THE SURGEON, IT WAS LEARNED THAT THE DEVICE WAS REMOVED PRIOR TO THE PATIENT COMING OFF CPB IN THIS CASE. THEREFORE, THERE WAS NO INCREASE IN RISK DUE TO THE EXPLANT. IT WAS ALSO CONFIRMED THAT THERE WAS NO MALFUNCTION OR DEFICIENCY OF THE VALVE. NO FURTHER ACTIONS ARE BEING TAKEN.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN AND EVALUATION. REASON FOR EXPLANT IS UNKNOWN. THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROGRESS.

    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 33 MM MITRAL VALVE WAS EXPLANTED AT IMPLANT AND REPLACED WITH A 31MM MITRAL VALVE - SAME MODEL DEVICE - DUE TO UNKNOWN REASONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX33

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R