BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1870089 · Received October 7, 2010

    Report

    Report Number
    2025587-2010-00120
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    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 CANNOT BE DETERMINED. NO MEDWATCH FORM WAS RECEIVED FROM THE USER FACILITY, THEREFORE, INFORMATION ON THE MEDWATCH FORM 3500A WAS 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." ANALYSIS: NO PRODUCT WAS RETURNED. 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. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THESE BIOPROSTHETIC VALVES, IMPLANTED 2.5 YEARS, WERE EXPLANTED (DOUBLE VALVE REPLACEMENT). IT WAS REPORTED THAT THE AORTIC VALVE WAS EXPLANTED AFTER THE PATIENT BECOME SHORT OF BREATH AND AN ECHOCARDIOGRAM REVIEW IDENTIFIED AORTIC REGURGITATION AND A GRADIENT INCREASE. AT EXPLANT, A PARACOMMISSURAL RUPTURE OF THE CUSP WAS IDENTIFIED.

    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