BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUIDANT - TETRA STENT

    MDR report key: 314685 · Received January 31, 2001

    Report

    Report Number
    314685
    Event Type
    Other
    Date Received
    January 31, 2001
    Date of Event
    December 26, 2000
    Report Date
    January 5, 2001
    Manufacturer
    GUIDANT ADVANCED CARDIOVASCULAR SYSEMS, INC.
    Product Code
    MAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: PTCA AND STENTING OF PROXIMAL LAD LESION. LESION WAS PREDILATED USING HIGH PRESSURE BALLOON (MAXUM) AS LESION WAS NOT EASILY DILATED. ATTEMPTED TO PASS TETRA STENT BUTT WAS UNSUCCESSFUL. WITHDREW BALLOON/STENT SYSTEM FROM CORONARY ARTERY AND INTO 6 FR. J L 4.0 GUIDANT GUIDE WITH LOSS OF STENT FROM BALLOON. UNDEPLOYED STENT RETRIEVED FROM AORTA USING GOOSE NECK SNARE. NO COMPLICATIONS RECONGNIZED. PROXIMAL LAD RE-DILATED THEN SUCCESSFUL DEPLOYMENT OF DIFFERENT TETRA STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3814 GUIDANT - TETRA STENT CORONARY ARTERY STENT MAF GUIDANT ADVANCED CARDIOVASCULAR SYSEMS, INC. UNK. 1005859-13 0110651

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other AS NOTED IN #5.