BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN PIVOT MECHANICAL HEART VALVE

    MDR report key: 1982662 · Received February 1, 2011

    Report

    Report Number
    2134151-2011-00001
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    MEDTRONIC ATS , INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6): EVALUATION 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 PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASE FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED FOR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MEDTRONIC REC'D INFORMATION THAT THIS MECHANICAL PROSTHESIS WAS ABANDONED AFTER IMPLANT. IT WAS REPORTED THAT ANATOMIC STRUCTURES PREVENTED THE VALVE LEAFLETS FROM PROPER CLOSING. A ROTATION OF THE VALVE WAS ATTEMPTED BUT DUE TO ANATOMICAL STRUCTURES, WAS UNSUCCESSFUL. THIS WAS THOUGHT TO BE DUE TO INTERACTION WITH THE VENTRICULAR MYOCARDIUM. THE VALVE WAS EXPLANTED AND REPLACED WITH A HANCOCK II VALVE. DURING THE PROCEDURE THE ANNULUS WAS DAMAGED AND A LEFT VENTRICULAR ASSIST DEVICE WAS IMPLANTED. IT WAS REPORTED THAT THE PT WAS REOPERATED (DUE TO BLEEDING) AND DIED 3 DAYS AFTER IMPLANT. THE CAUSE OF DEATH IS UNK. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT REC'D. IT IS UNK IF AN AUTOPSY WAS OR WILL BE PERFORMED.

    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 Required Intervention