BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS® LD ILIAC / BILIARY

    MDR report key: 2831301 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-07086
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A BREAK AT THE PROXIMAL EDGE OF THE PROXIMAL BALLOON SLEEVE. IT WAS ALSO NOTED THAT THE SHAFT WAS STRETCHED. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. AN EXAMINATION OF THE BALLOON FOUND NO TEARS OR HOLES IN THE BALLOON. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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 REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE 9.0 X 40 X 75 CM EXPRESS LD ILIAC / BILIARY STENT WAS SUCCESSFULLY DEPLOYED IN THE PATIENT. UPON REMOVAL OF THE STENT DELIVERY SYSTEM THE CATHETER SHAFT FRACTURED AND SEPARATED. THE DISTAL SHAFT SECTION AND BALLOON WERE REMOVED INSIDE THE ACCESS SHEATH. NO ADDITIONAL INTERVENTION WAS REQUIRED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE 9.0X40X75CM EXPRESS LD ILIAC / BILIARY STENT WAS SUCCESSFULLY DEPLOYED IN THE PATIENT. UPON REMOVAL OF THE STENT DELIVERY SYSTEM THE CATHETER SHAFT FRACTURED AND SEPARATED. THE DISTAL SHAFT SECTION AND BALLOON WERE REMOVED INSIDE THE ACCESS SHEATH. NO ADDITIONAL INTERVENTION WAS REQUIRED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS® LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046940750 15043260

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR