BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS® LD ILIAC / BILIARY

    MDR report key: 2801932 · Received October 23, 2012

    Report

    Report Number
    2134265-2012-06373
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 FURTHER REPORTED THAT VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION LOCATED IN THE ILIAC ARTERY WAS 90% STENOSED NON-TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED. FOLLOWING REMOVAL OF THE RUPTURED BALLOON IN THE ACCESS SHEATH AS PREVIOUSLY REPORTED. THE IMPLANTED STENT REQUIRED POST DILATION WAS PERFORMED FROM THE LEFT FEMORAL ARTERY, ACCESS FROM THE LEFT FEMORAL ARTERY WAS REQUIRED DUE TO THE REMOVAL OF THE RIGHT FEMORAL ACCESS SHEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE AND MATERIAL DETACHMENT OCCURRED. UPON DEPLOYMENT OF THE 8.0X40MM 75CM EXPRESS LD STENT THE BALLOON RUPTURED. UPON WITHDRAWAL OF THE DEVICE THE BALLOON SHEARED OFF THE TIP OF THE CATHETER. THE DETACHED SECTION OF THE BALLOON WAS REMOVED INSIDE THE 6FR ACCESS SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS® LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046840750 14975414

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other