BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM

    MDR report key: 1823007 · Received September 1, 2010

    Report

    Report Number
    2134265-2010-03856
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, THE STENT MOVED ON THE BALLOON. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY USING A CONTRALATERAL APPROACH. TWO NON-BSC STENTS WERE IMPLANTED IN THE EXTERNAL ILIAC ARTERY, JUST BELOW THE AORTIC BIFURCATION. THEN THE PHYSICIAN ADVANCED THIS 8.0X40X75CM EXPRESS LD STENT THROUGH ANOTHER MANUFACTURERS' 6F INTRODUCER SHEATH TO IMPLANT IN THE RIGHT COMMON ILIAC ARTERY. THE ANATOMY WAS MODERATELY TORTUOUS WHERE THE INTRODUCER SHEATH WAS LOCATED. UPON ADVANCEMENT THROUGH THE INTRODUCER SHEATH, ANGIO WAS PERFORMED, AND IT WAS NOTED THE STENT HAD MOVED OVER THE PROXIMAL MARKER BAND. THE STENT WAS STILL LOCATED ON THE BALLOON. THE STENT WAS STILL DELIVERED TO THE LESION AND IMPLANTED WITHOUT DIFFICULTIES. STENT FINAL POSITION WAS WELL POSITIONED AND WELL APPOSED. THE PROCEDURE WAS CONSIDERED COMPLETE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. THIS PRODUCT IS ONLY (B)(4) APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    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 H74938162730750 13218719

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: TERUMO DESTINATION 6F