BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2103171 · Received May 25, 2011

    Report

    Report Number
    2015691-2011-15608
    Event Type
    Death
    Date Received
    May 25, 2011
    Date of Event
    February 3, 2011
    Report Date
    April 26, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.ADDITIONAL MANUFACTURER NARRATIVE:THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS.THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE REPORTED "PROBABLE" TORN OUT STITCH FROM THE VALVE CANNOT BE POSITIVELY IDENTIFIED.THE INVESTIGATION REVEALS NOTHING TO INDICATE A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT.

    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 (B)(4) 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, INITIALLY REPORTED AS [SUBJECT] VALVE EXPLANT AT IMPLANT AND REPLACED WITH SAME MODEL EDWARDS' VALVE (REFERENCE SN (B)(4)). HOWEVER, THROUGH FOLLOW-UP, LEARNED THAT THE PATIENT EXPIRED 7 DAYS POST SURGERY DUE TO A LARGE LEFT BRAIN STROKE. OPERATIVE REPORT INDICATES, " [SUBJECT] VALVE SEATED NICELY 'THE PATIENT WAS THEN ADEQUATELY REPERFUSED AND REWARMED A TEE SHOWED NO PERIPROSTHETIC INSUFFICIENCY, EXCELLENT CARDIAC FUNCTION, HOWEVER, THERE WAS A GENEROUS SYSTOLIC FLOW BELOW THE LEVEL OF THE AORTIC VALVE, WHICH APPEARS TO BE IN THE SEPTUM, HOWEVER IT WAS NOT A VENTRICULAR SEPTAL DEFECT, AS THERE IS NOT FLOW INTO THE RIGHT VENTRICLE DETAILED EXAMINATION THEN REVEALED THERE WAS A PERFORATION OF THE AORTA BELOW THE LEVEL OF THE VALVE IMPLANTATION, AND THIS PROBABLY CORRESPONDED TO THE SEPTAL DEFECT ON THE TEE, WHICH LED TO AN EXTERNAL PERFORATION, PROBABLY DUE TO A TORN OUT STITCH FROM THE VALVE[THEN] HAD TO REMOVE THE PREVIOUSLY PLACED VALVE [FOR REPAIR]." DISCHARGE SUMMARY INDICATES, " ON POD #2, PATIENT RETURNED TO OR FOR EVACUATION OF RIGHT HEMOTHORAX WITH NO SURGICAL BLEEDING...THE PATIENT WAS ABLE TO MOVE HER LEFT UPPER EXTREMITY BUT HAS SOME SLOWED MOVEMENT ON HER RIGHT SIDE. ON POD #7, THE PATIENT REMAINED HEMODYNAMICALLY STABLE. WERE ABLE TO REMOVE THE SWAN-GANZ CATHETER. THE PATIENT CONTINUED TO BE THROMBOCYTOPENIC...CT SCAN UNFORTUNATELY SHOWED A LARGE LEFT BRAIN STROKE. THIS WAS ON THE SIDE OF THE UNOPERATED CARTOID SIDE...SUPPORT WAS WITHDRAWN"

    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-10L3131

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| R