BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1941755 · Received December 20, 2010

    Report

    Report Number
    2025587-2010-00172
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    September 29, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT DETERMINED TO BE PATIENT RELATED. ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, TWO TISSUE SAMPLES HAD BEEN REMOVED DURING EXPLANT FROM THE LEFT AND RIGHT CUSPS FOR HOSPITAL PATHOLOGY. ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE EXCEPT WHERE THROMBOTIC HOST TISSUE LINED THE OUTFLOW. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE AND/OR HOST TISSUE. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. REDUCED PERFORMANCE OF THE VALVE IS ATTRIBUTED TO THROMBUS. THESE FINDINGS ARE GENERALLY CONSIDERED A PATIENT RELATED CONDITION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED 3.5 YEARS, WAS EXPLANTED DUE TO STRUCTURAL DYSFUNCTION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    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 83 YR Required Intervention