BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUIDANT

    MDR report key: 199385 · Received November 25, 1998

    Report

    Report Number
    199385
    Event Type
    Other
    Date Received
    November 25, 1998
    Date of Event
    October 26, 1998
    Report Date
    November 25, 1998
    Manufacturer
    GUIDANT ADV. CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD HEART CATHERIZATION WITH STENT PLACEMENT. INITIAL STENT USED DID NOT DEPLOY. EFFORTS TO RECOVER THE MISSING STENT FAILED. STENT REMAINS IN THE PT WITHOUT CAUSING CLINICAL PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT Implant ACS RX MULTI-LINK HP STENT MAF GUIDANT ADV. CARDIOVASCULAR SYSTEMS, INC. * 8083151

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other