BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK STANDARD MITRAL HEART VALVE

    MDR report key: 102505 · Received June 30, 1997

    Report

    Report Number
    2025587-1997-00091
    Event Type
    Injury
    Date Received
    June 30, 1997
    Date of Event
    May 12, 1997
    Report Date
    June 11, 1997
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H10. THIS MEDWATCH FOLLOW-UP REPORT IS BEING SENT TO PROVIDE ADDITIONAL INFORMATION RECEIVED BY THE USER FACILITY AFTER THE FIRST REQUIRED REPORT WAS FILED BY THE MANUFACTURER. "SUBMISSION OF INFORMATION BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THIS INFORMATION IS REQUIRED TO BE REPORTED UNDER THE REGULATION OR THAT THE DEVICE HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY OR DEATH THAT MAY HAVE OCCURRED." H11 OTHER: THE PATIENT IDENTIFIER A.1 ON THE ORIGINAL MANUFACTURERS REPORT WAS 1970135 - THE USER FACILITY REPORT ENTERS THE PATIENT IDENTIFIER AS J1970135. B.4 AND F.8 ON THE USER FACILITY REPORT IS LISTED AS 9/29/97 -- THE MANUFACTURERS REPORT LISTED 6/11/97 AS THIS WAS THE DATE THE EVENT WAS FIRST REPORTED TO MEDTRONIC. A LETTER FROM THE USER FACILITY IS ATTACHED TO EXPLAIN THE REASON FOR THE DELAY FROM THE USER FACILITY. REASON: THE USER FACILITY DID NOT CONSIDER THIS A DEVICE FAILURE OR DEFECT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT THE VALVE WAS EXPLANTED APPROXIMATELY 58 MONTHS POST IMPLANT DUE TO REGURGITATION. THE VALVE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANCOCK STANDARD MITRAL HEART VALVE Implant BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC. 342 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R