BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM

    MDR report key: 1993410 · Received February 16, 2011

    Report

    Report Number
    2134265-2011-00416
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. 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, A VESSEL DISSECTION AND PERFORATION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE MODERATELY STENOSED DE NOVO LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY TO MODERATELY CALCIFIED LEFT COMMON ILIAC (CIA) ARTERY. THE LESION WAS PREDILATED WITH A 8MM BALLOON CATHETER WITH MINIMAL RESIDUAL STENOSIS. A 9.0X40X75CM EXPRESS LD ILIAC/BILIARY STENT DELIVERY SYSTEM WAS ADVANCED AND THE STENT WAS DEPLOYED. AFTER THE DELIVERY BALLOON WAS DEFLATED, A VESSEL PERFORATION WITH EXTRAVASATIONS WAS NOTED LATERAL TO THE STENT. TO TREAT THE PERFORATION THE DELIVERY BALLOON WAS INFLATED AND HELD FOR AN UNSPECIFIED DURATION, BUT DID NOT SEAL THE VESSEL. NEXT, ANOTHER MANUFACTURER'S COVERED STENT WAS IMPLANTED; HOWEVER, THERE APPEARED TO BE A LEAK BEHIND THE STENT. IT WAS DETERMINED THAT THE LATERAL DISSECTION HAD TURNED INTO A VESSEL PERFORATION. AS A RESULT, THE BLEEDING WAS CONTROLLED BY INFLATING THE NON-BSC STENT DELIVERY BALLOON "FOR QUITE SOME TIME". THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    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 H74938046940750 12781798

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention