BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM

    MDR report key: 1275006 · Received December 23, 2008

    Report

    Report Number
    2134265-2008-04933
    Event Type
    Injury
    Date Received
    December 23, 2008
    Date of Event
    November 24, 2008
    Report Date
    November 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K021630
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN 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.

    Description of Event or Problem · 1

    SAME CASE AS MFR#213465-2008-04934, 2134265-2008-04935, 2134265-2008-04936. IT WAS REPORTED THAT DURING A BALLOON ANGIOPLASTY PROCEDURE, A VESSEL PERFORATION OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE HIGHLY CALCIFIED ILIAC ARTERY. THE PHYSICIAN USED A 5.0 X 60MM AND A 6.0 X 60MM ULTRA-THIN SDS BALLOON CATHETER TO PREDILATE THE LESION. DUE TO ARTERY RECOILING, THE PHYSICIAN THEN USED ANOTHER MANUFACTURER'S HIGH PRESSURE BALLOON TO DILATE THE LESION WITH GOOD RESULTS. THE PHYSICIAN SUCCESSFULLY DEPLOYED TWO EXPRESS BILIARY LD STENTS. FOLLOWING STENTING, THERE APPEARED TO BE A PERFORATION OF THE ILIAC ARTERY. THE PHYSICIAN THEN "TOOK A COVERED BALLOON EXPANDABLE STENT TO PUT OVER THE PERFORATION. NO ISSUES BLOOD PRESSURE OR PAIN. PERFORATION WAS UNDER CONTROL, WOUND CLOSE AND HEAL". NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS WAS REPORTED AS STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention