BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPEN PIVOT MECHANICAL HEART VALVE

    MDR report key: 2091112 · Received May 6, 2011

    Report

    Report Number
    2134151-2011-00007
    Event Type
    Death
    Date Received
    May 6, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC ATS, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    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 CANNOT BE DETERMINED. 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, HOWEVER, IT IS POSSIBLE THAT THE EFFECTS OF ENDOCARDITIS ON THE TISSUE CONTRIBUTED TO THE PARAVALVULAR LEAKS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT WITHIN 30 DAYS FOLLOWING IMPLANT OF THESE AORTIC AND MITRAL MECHANICAL VALVES (EXACT DATE OF IMPLANT UNKNOWN), THE PATIENT DIED DURING A VALVE RE-OPERATION. THERE WAS NO EVIDENCE OF PARAVALVULAR LEAK WITH EITHER VALVE DURING OR IMMEDIATELY FOLLOWING IMPLANT, HOWEVER, SHORTLY AFTER IMPLANT (EXACT DATE UNKNOWN), ECHOCARDIOGRAPHY FINDINGS REVEALED THAT BOTH VALVES HAD PARAVALVULAR LEAKS. THE VALVES WERE SUCCESSFULLY REPAIRED BUT THE PATIENT DID NOT COME OFF CARDIOPULMONARY BYPASS AND DIED. THE VALVES WERE INITIALLY IMPLANTED DUE TO ENDOCARDITIS. THE VALVES WERE NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPEN PIVOT MECHANICAL HEART VALVE LWQ MEDTRONIC ATS, INC. 500DM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death