BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 2171083 · Received July 8, 2011

    Report

    Report Number
    2025587-2011-00078
    Event Type
    Injury
    Date Received
    July 8, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: DEVICE HISTORY COULD NOT BE REVIEWED AS A SERIAL NUMBER WAS NOT PROVIDED. RESULTS: NO PRODUCT WAS RETURNED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THROUGH LITERATURE REVIEW (ANN THORAC SURG 2011;91;E90-1) THAT THIS BIOPROSTHETIC VALVE WAS EXPLANTED DUE TO THROMBOSIS. IT WAS REPORTED THE PT WAS (B)(6) YEARS OLD, POSITIVE FOR (B)(6). THE PT PRESENTED 2 YEARS AFTER IMPLANT WITH SYNCOPE ON EXERTION. TRANSVALVULAR AORTIC MEAN GRADIENT WAS APPROX 50 MM/HG ON ECHOCARDIOGRAM AND CATHETERIZATION. CARDIAC COMPUTED TOMOGRAPHY SCAN SHOWED A LIMITED OPENING OF THE BIOPROSTHESIS CUSPS. TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED NO SINGS OF DETERIORATION OF THE BIOPROSTHESIS. SURGICAL EXPLORATION REVEALED THROMBOSIS OF THE THREE CUSPS ON THE AORTIC SIDE, LIMITING THE OPENING OF THE VALVE. THE VALVE WAS REPLACED WITH A SIZE 21 BILEAFLET MECHANICAL VALVE. POST-OPERATIVELY, THE PT HAD PERSISTENT ATRIOVENTRICULAR NODE BLOCK. ANTICOAGULATION THERAPY WAS STARTED. ON POST-OPERATIVE DAY 10, THE PT HAD A STROKE WITH LEFT-SIDED HEMIPLEGIA AND APHASIA, CONFIRMED BY A HEAD COMPUTED TOMOGRAPHY SCAN THAT SHOWED A RIGHT MIDDLE CEREBRAL ARTERY OCCLUSION. TRANSTHORACIC ECHOCARDIOGRAPHY SHOWED NO EVIDENCE OF THROMBUS NOR AN AORTIC TRANSVALVULAR GRADIENT. THE PT RECOVERED PARTIALLY FROM THE STROKE AND WAS DISCHARGED TO A REHABILITATION FACILITY ON POST-OPERATIVE DAY 15. NO RELATION COULD BE ESTABLISHED BETWEEN THE PT'S HUMAN IMMUNODEFICIENCY VIRUS STATUS AND VALVE THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC. 305 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention