BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS? VASCULAR SD

    MDR report key: 3161637 · Received June 11, 2013

    Report

    Report Number
    2134265-2013-04420
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND NON TORTUOUS UNSPECIFIED ARTERY. A 5.0MM X 19MM X 90CM EXPRESS VASCULAR SD METALLIC STENT WAS SELECTED TO TREAT THE TARGET LESION. DURING THE ATTEMPT TO CROSS THE TARGET LESION, THE STENT WAS DISLODGED. THE STENT WAS LOCATED AND IMPLANTED ON THE EXTERNAL ILIAC. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER REASON. NO COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261992 EXPRESS? VASCULAR SD CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937918519900 0015361709

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention