BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK .035 STENT DELIVERY SYSTEM

    MDR report key: 1144225 · Received August 29, 2008

    Report

    Report Number
    3004742046-2008-00205
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K060817
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND OTW OMNI 35 PN 1008182-28, LOT # 8040151, REFERENCED WILL BE FILED RESPECTIVELY UNDER THE SAME MANUFACTURER REPORT NUMBER. A REVIEW OF BOTH FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. NO ROOT CAUSE WAS IDENTIFIED FOR THE STENT DISLODGEMENTS WHICH CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, PRE-DILATATION STRATEGY, PT ANATOMICAL MORPHOLOGY, AND PT DISEASE STATE. THE OMNILINK .035" BILIARY STENT DELIVERY SYSTEM IS INTENDED FOR PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE. ALL OMNILINK BALLOON CRIMPED STENTS ARE 100% VISUALLY INSPECTED IN THE MANUFACTURING PROCESS AT ABBOTT VASCULAR.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: STENT DISLODGEMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A BILATERAL AORTOILIAC STENOSIS "KISSING STENT" PROCEDURE, THE STENTS CAME OFF THE BALLOON PREMATURELY. THE PHYSICIAN EMBEDDED THE DISLODGED STENTS AGAINST THE VESSEL WALL IN AN UNINTENDED SITE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. ALTHOUGH REQUESTED, THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNILINK .035 STENT DELIVERY SYSTEM FGE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7040352

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OTW OMNI 35 1008182-28