BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM

    MDR report key: 2042605 · Received April 6, 2011

    Report

    Report Number
    2134265-2011-01228
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL INTERVENTION TREATMENT PROCEDURE, A STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC ARTERY (CIA). A NON BSC GUIDE CATHETER WAS SELECTED FOR USE BUT WAS UNABLE TO ADVANCE UP AND OVER THE BIFURCATION OF THE COMMON ILIAC ARTERY. AS A RESULT THE TIP OF THE NON BSC CATHETER WAS PARKED AT THE BIFURCATION. TWO ULTRA-THIN BALLOONS WERE SUCCESSFULLY ADVANCED OVER THE BIFURCATION. NEXT, THE 8.0X30X75CM EXPRESS VASCULAR LD STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER THE BIFURCATION TO STENT THE LEFT ILIAC ARTERY. THE SDS 'GOT STUCK' ONCE IT PASSED THE BIFURCATION. AT THIS POINT, THE PHYSICIAN DECIDED TO RETREAT AND BEGAN RETRIEVING THE DEVICE AS THE DEVICE WAS UNABLE TO FURTHER ADVANCE. DURING RETRIEVAL OF THE SDS THE STENT DISLODGED AND REMAINED IN THE RIGHT COMMON ILIAC BIFURCATION. A SNARING DEVICE WAS USED TO CAPTURE THE DISLODGED STENT SUCCESSFULLY. NO FURTHER COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162830750 14046281

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE CATHETER, BALKIN