BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2072793 · Received April 29, 2011

    Report

    Report Number
    2015691-2011-15361
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    November 4, 2010
    Report Date
    March 29, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO ADDITIONAL INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED, NOT RETURNED FOR EVALUATION. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WILL BE REPORTED ONCE COMPLETED. WITHOUT RETURN OF SUBJECT DEVICE FOR EVALUATION AND ANALYSIS, THE ROOT CAUSE OF THIS EXPLANT CANNOT BE IDENTIFIED. THE SURGEON INDICATED THAT THE REASON FOR EXPLANT IS NOT RELATED TO EDWARDS' DEVICE MALFUNCTION.

    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, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED AT IMPLANT AND REPLACED WITH ANOTHER VALVE, DUE TO A PARAVALVULAR LEAK. PER OPERATIVE REPORT, " THE [SUBJECT] VALVE WAS SEATED WITHOUT DIFFICULTY AND TIED INTO POSITION. NO PERIPROSTHETIC LEAK COULD BE IDENTIFIED AND BOTH CORONARY OSTIA WERE READILY IDENTIFIED ABOVE THE LEVEL OF THE SEWING RING. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS, BUT A PARAVALVULAR LEAK WAS IDENTIFIED WHICH WAS NOT INSIGNIFICANT...CARDIOPULMONARY BYPASS WAS REINSTITUTED...THE VALVE WAS INSPECTED AND THE SUGGESTION OF A LEAK WAS IDENTIFIED AT THE COMMISSURE BETWEEN THE LEFT CORONARY CUSP AND THE RIGHT CORONARY CUSP... A BRIEF ATTEMPT TO DISCONTINUE CARDIOPULMONARY BYPASS WAS MADE, BUT SIGNIFICANT AORTIC INSUFFICIENCY IN A PARAVALVULAR LOCATION WAS STILL EVIDENT. CARDIOPULMONARY BYPASS WAS REINSTITUTED AND SYSTEMIC COOLING PERFORMED. AFTER VALVE WAS EXPLANTED, IT WAS EVIDENT THAT THE PARAVALVULAR LEAK HAD BEEN ON THE COMMISSURE BETWEEN THE NON CORONARY CUSP AND THE RIGHT CORONARY CUSP, BUT HIS WAS NOT EVIDENT WHILE THE VALVE WAS SEATED. THE ANNULUS OF THE VALVE WAS FURTHER DEBRIDED IN THIS LOCATION."

    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 R-10J2390

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R