BEUDAMED
    FDA Adverse Event Death Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1982781 · Received February 1, 2011

    Report

    Report Number
    2025587-2011-00005
    Event Type
    Death
    Date Received
    February 1, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    MEDTRONIC HEART VALVES, INC
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: DEVICE HISTORY COULD NOT BE REVIEWED AS NO SERIAL NUMBER WAS PROVIDED. RESULTS: NO PRODUCT WAS RETURNED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: THE CAUSE OF DEATH IS UNK. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT REC'D. IT IS UNK IF AN AUTOPSY WAS OR WILL BE PERFORMED. SHOULD ADDITIONAL INFORMATION BE REC'D, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC T505 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death