BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1931059 · Received December 7, 2010

    Report

    Report Number
    2025587-2010-00157
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 11, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCLUSION: CAUSE OF EVENT DETERMINED TO BE CAUSED BY OPERATIONAL CONTEXT. ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE POSSIBLY DUE TO THE TAN SOLUTION THE VALVE WAS RECEIVED IN AND/OR THE DECONTAMINATION PROCESS. A LARGE PERFORATION IN THE BELLY OF THE NON-CORONARY CUSP APPEARS TO BE DUE TO A SHARP OBJECT SUCH AS FORCEPS. NOTE: DUE TO THE LARGE PERFORATION, PULSE DUPLICATION TESTING WILL NOT BE PERFORMED. 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. ANALYSIS SUGGESTS THAT THE VALVE WAS DAMAGED DURING THE IMPLANT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE WAS ABANDONED AFTER IMPLANT. IT WAS REPORTED THAT THE VALVE WAS SEATED AND WHEN THE HOLDER WAS CUT OFF THE VALVE, ONE LEAFLET LOOKED MORE "CURLED" THAN THE OTHERS. THE SURGEON WAS NOT COMFORTABLE THAT THE VALVE WOULD BE COMPETENT, SO IT WAS REMOVED AND ANOTHER VALVE WAS SUCCESSFULLY IMPLANTED. 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 Required Intervention