BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1658003 · Received April 9, 2010

    Report

    Report Number
    2025587-2010-00031
    Event Type
    Death
    Date Received
    April 9, 2010
    Date of Event
    January 22, 2010
    Report Date
    March 16, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT DETERMINED TO BE USER ERROR. ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, ALL LEAFLETS WERE FLEXIBLE. THE RIGHT AND NON-CORONARY CUSPS WERE INTACT. A LARGE PERFORATION THROUGH THE FREE MARGIN AND LUNULA OF THE LEFT CUSP ADJACENT TO THE NON-CORONARY LEFT COMMISSURE APPEARED TO HAVE OCCURRED DURING IMPLANT WITH A SHARP OBJECT, SUCH AS A FORCEPS. CONCLUSION: THE DHR OF THIS DEVICE WAS REVIEWED TO FIND NO ISSUES THAT WOULD HAVE IMPACTED THIS EVENT. ANALYSIS CONFIRMED THAT THE DAMAGE TO THE VALVE WAS INDUCED DURING THE IMPLANT. MEDTRONIC HAS MADE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CAUSE AND NATURE OF THE HEMORRHAGE, HOWEVER, NO ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE WAS ABANDONED AFTER IMPLANT, DUE TO A CUSPAL TEAR. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT DIED INTRA-OPERATIVELY FROM "RIGHT HEART FAILURE AND HEMORRHAGE."

    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 Death