BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM

    MDR report key: 1951104 · Received January 6, 2011

    Report

    Report Number
    2134265-2010-05972
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 PERIPHERAL STENTING TREATMENT PROCEDURE THE STENT DISLODGED INSIDE THE PATIENT. THE 90% STENOSED LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. AS THE PHYSICIAN ADVANCED THE 7.0MM X 30MM X 75CM EXPRESS LD ILIAC/BILIARY STENT DELIVERY SYSTEM (SDS) THROUGH THE LESION, RESISTANCE WAS ENCOUNTERED AND 'STRONG FORCE' WAS USED TO ADVANCE THE EXPRESS STENT ACROSS THE LESION. THE STENT WAS UNABLE TO CROSS THE LESION. AS THE PHYSICIAN WITHDREW THE EXPRESS LD FROM THE LESION, THE EXPRESS STENT DISLODGED FROM THE BALLOON. THE PHYSICIAN ADVANCED A SMALLER BALLOON CATHETER THROUGH THE DISLODGED EXPRESS STENT AND DEPLOYED THE STENT 'A LITTLE BIT ABOVE THE LESION' TO THE COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE EXPRESS LD STENT WAS IMPLANTED OVER THE DISTAL END OF THE LESION WHICH RESULTED IN 3MM OF THE PROXIMAL PORTION OF THE LESION UNCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046730750 0012797817

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention