BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM

    MDR report key: 1843056 · Received September 23, 2010

    Report

    Report Number
    2134265-2010-04429
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER.(B)(4).DEVICE EVALUATED BY MFR: 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 PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT COMMON ILIAC ARTERY (CIA). PRE-DILATATION WAS NOT PERFORMED. THE 10.0X40X75CM EXPRESS VASCULAR LD WAS ADVANCED INTO THE PATIENT, BUT WAS NOT ABLE TO CROSS THE LESION. WHILE WITHDRAWING THE DEVICE, THE STENT BECAME DISLODGED IN THE 7FR NON BSC INTRODUCER SHEATH. THE SHEATH AND THE DISLODGED STENT WERE REMOVED TOGETHER. ANOTHER 7FR INTRODUCER SHEATH WAS PLACED AND PRE-DILATATION WAS PERFORMED. A 9.0MM EXPRESS VASCULAR LD STENT WAS THEN ABLE TO BE IMPLANTED IN THE TARGET LESION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD. THIS PRODUCT IS ONLY OUS 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 H74938162104070 12956889

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7FR BRITE TIP INTRODUCER SHEATH