BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK .035 STENT DELIVERY SYSTEM

    MDR report key: 1161553 · Received September 15, 2008

    Report

    Report Number
    3004742046-2008-00217
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 25, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K060817
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (OFF LABEL VASCULAR USE). THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: STENT DISLODGEMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE IN THE ILIAC ARTERY, THE OMNILINK STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH AND EXITED THE INTRODUCER SHEATH NEAR THE AORTIC BIFURCATION. THE SDS DID NOT ADVANCE THROUGH THE VESSEL BUT "NOSED INTO" THE WALL OF THE LEFT COMMON ILIAC ARTERY. THE SDS WAS COMPLETELY REMOVED FROM THE BODY AND WAS REINSERTED AND ADVANCED THROUGH THE SHEATH A SECOND TIME. AT THE DISTAL END OF THE SHEATH, NEAR THE AORTIC BIFURCATION, IT WAS FLUOROSCOPICALLY OBSERVED THAT STENT HAD DISLODGED, UNEXPANDED, ONTO THE SHAFT. THE SDS AND ATTACHED STENT WERE REMOVED FROM THE BODY WITHOUT DIFFICULTY AND A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. 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 8043051

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK