BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS RX MULTILINK 3.0 X15MM

    MDR report key: 159304 · Received March 24, 1998

    Report

    Report Number
    159304
    Event Type
    Injury
    Date Received
    March 24, 1998
    Date of Event
    March 18, 1998
    Report Date
    March 24, 1998
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEM
    Product Code
    MAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN THE CARDIOVASCULAR LABORATORY. ATTEMPTING TO POSITION STENT, BUT UNABLE TO CROSS LESION. ATTEMPTED TO WITHDRAW AND STENT CAME OFF DELIVERY BALLOON. UNABLE TO RETRIEVE STENT WITH SNARE OR WIRE. PT TAKEN TO SURGERY FOR TRIPLE BI-PASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS RX MULTILINK 3.0 X15MM Implant STENT MAF ADVANCED CARDIOVASCULAR SYSTEM 1001091-U 8013051

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R