BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK .035 STENT DELIVERY SYSTEM

    MDR report key: 1430143 · Received May 8, 2009

    Report

    Report Number
    3004742046-2009-00108
    Event Type
    Malfunction
    Date Received
    May 8, 2009
    Date of Event
    April 21, 2009
    Report Date
    April 21, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K053459
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): (OFF LABEL USE IN THE VASCULATURE). (B)(4). DEVICE #2 - AGILTRAC PART # 1010007-40, LOT # 8050251 IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. THE DEVICE HAS BEEN RECEIVE; HOWEVER, THE INVESTIGATION IS NOT YET COMPLETE. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ANY ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE #1 MALFUNCTION: BALLOON RUPTURE. TIME OF DEVICE MALFUNCTION: DURING PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN OMNILINK STENTING PROCEDURE IN THE DISTAL AORTA, DURING BALLOON INFLATION AND STENT DEPLOYMENT, THE BALLOON RUPTURED AT 12 ATMS. THE STENT WAS DEPLOYED SUCCESSFULLY AT THE INTENDED SITE AND THE STENT DELIVERY SYSTEM AND BALLOON WERE REMOVED FROM THE PT ANATOMY WITHOUT DIFFICULTY. DURING POST DILATATION, THE AGILTRAC BALLOON RUPTURED AT 12 ATMS. THE BALLOON WAS REMOVED FROM THE PT ANATOMY INTACT AND SUCCESSFUL DILATATION WAS ACHIEVED. THERE WERE NO ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNILINK .035 STENT DELIVERY SYSTEM FGE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8041051

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PART # 1010007-40, LOT # 8050251.| DILATATION CATHETER: DEVICE #2, AGILTRAC