BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 2091462 · Received May 5, 2011

    Report

    Report Number
    2025587-2011-00060
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 15, 2011
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. CONCLUSIONS: CAUSE OF EVENT DETERMINED TO BE RELATED TO PATIENT CONDITION. NO MEDWATCH FORM WAS RECEIVED FROM THE USER FACILITY, THEREFORE, INFORMATION ON THE MEDWATCH FORM 3500A WS COMPLETED BY MEDTRONIC WITH INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL. "ANY MISSING OR INCOMPLETE DATA ON FORM 3500A ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY THE REPORTER. DESPITE ATTEMPTS TO OBTAIN SUCH INFORMATION FROM THE REPORTER, MEDTRONIC IS UNABLE TO COMPLETE FORM 3500A." UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL EXAMINATION REVEALED EXTENSIVE TISSUE DETERIORATION DUE TO VISIBLE MINERALIZATION IN ALL CUSPS. TISSUE DETERIORATION DUE TO MINERALIZATION WAS NOTED IN ALL COMMISSURES. A REMNANT OF PANNUS WAS NOTED ALONG THE INFLOW OF THE NON-CORONARY COMMISSURE. RADIOGRAPHY SHOWS EXTENSIVE MINERALIZATION FILLING ALL CUSPS ON THE OUTFLOW. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS VALVE 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 EXTENSIVE MINERALIZATION AND HOST TISSUE OVERGROWTH. THERE FINDINGS ARE GENERALLY CONSIDERED A PATIENT RELATED CONDITION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED 1 YEAR, WAS EXPLANTED DUE TO STENOSIS. 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 72 YR Required Intervention