BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 2142338 · Received June 20, 2011

    Report

    Report Number
    2025587-2011-00074
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 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). EVALUATION METHOD: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT ATTRIBUTED TO PATIENT CONDITION. ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, THE VALVE TISSUE WAS DARK AND MODERATELY DESICCATED, POSSIBLY DUE TO THE SOLUTION THE VALVE HAD BEEN PLACED IN POST-PROCEDURE. ALL LEAFLETS WERE STIFF, PARTIALLY DUE TO THE RECEIPT CONDITION, BUT MODERATELY FLEXIBLE. TISSUE DISRUPTION ON THE TUNICA OF THE LEFT AND RIGHT CUSP APPEARED TO BE DUE TO THE REMOVAL OF HOST TISSUE DURING EXPLANT. A TINY ABRASION WAS NOTED ON THE FREE MARGIN OF THE RIGHT CUSP ADJACENT TO THE POINT OF COAPTATION. THE NON-CORONARY LEFT AND LEFT RIGHT COMMISSURES WERE INTACT. A TEAR IN THE RIGHT NON-CORONARY COMMISSURE APPEARED TO HAVE OCCURRED DURING EXPLANT. PANNUS LINED THE OUTFLOW RAIL OF THE RIGHT CUSP, ALONG THE OUTFLOW MARGIN OF ATTACHMENT TO THE LEFT RIGHT AND RIGHT NON-CORONARY STENT POSTS AND COMMISSURAL AREAS. THE TEAR LINE ON THE TUNICA OF THE RIGHT CUSP SHOWS EVIDENCE THAT PANNUS MAY HAVE EXTENDED 1 TO 7 MM ONTO THE RIGHT CUSP REDUCING THE INFLOW ORIFICE AREA. IT APPEARED THAT PANNUS HAD BEEN REMOVED ON THE INFLOW AND OUTFLOW DURING EXPLANT. SMALL CLUSTERS OF TAN THROMBOTIC HOST TISSUE LINED THE OUTFLOW MARGIN OF ATTACHMENT OF ALL CUSPS. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE AND/OR HOST TISSUE. 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 HOST TISSUE OVERGROWTH. THESE FINDINGS ARE GENERALLY CONSIDERED A PATIENT RELATED CONDITION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED OVER 2 YEARS, WAS EXPLANTED DUE TO AORTIC STENOSIS. NO ADVERSE PATIENT EFFECTS WERE 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 51 YR Required Intervention