BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1861921 · Received September 30, 2010

    Report

    Report Number
    2025587-2010-00115
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS - DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION - CAUSE OF EVENT DETERMINED TO BE DUE TO USER ERROR. ANALYSIS - UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, THE NON-CORONARY AND LEFT CUSPS WERE INTACT. A TEAR IN THE LUNULA OF THE RIGHT CUSP ADJACENT TO THE LEFT RIGHT COMMISSURE APPEARED TO BE DUE TO A SHARP OBJECT SUCH AS FORCEPS. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MFG SPEC FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. ANALYSIS FINDINGS CONCLUDED THAT THE TEAR WAS DUE TO USER ERROR.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC VALVE WAS ABANDONED AFTER THE VALVE WAS SEATED. IT WAS REPORTED THAT WHILE REMOVING THE VALVE HOLDER A HOLE WAS FOUND IN ONE OF THE LEAFLETS CLOSE TO THE TO TOP.

    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 Required Intervention