BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS® LD ILIAC / BILIARY

    MDR report key: 3122752 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03516
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION FOUND NO ISSUES WITH THE DEVICE. THE CRIMPED STENT, BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN ILIAC ANGIOPLASTY PROCEDURE, THE STENT MOVED ON THE BALLOON. A 6.0 X 30 X 75 CM EXPRESS LD ILIAC / BILIARY STENT WAS SELECTED. WHEN THEY TOOK IT OUT OF THE HOOP, THEY NOTICED THAT THE STENT WAS HALF OFF THE BALLOON. IT NEVER WENT INSIDE THE PATIENT'S BODY. GRABBED ANOTHER STENT OF THE SAME SIZE AND MODEL THEN COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN ILIAC ANGIOPLASTY PROCEDURE, THE STENT MOVED ON THE BALLOON. A 6.0 X 30 X 75 CM EXPRESS LD ILIAC / BILIARY STENT WAS SELECTED. WHEN THEY TOOK IT OUT OF THE HOOP, THEY NOTICED THAT THE STENT WAS HALF OFF THE BALLOON. IT NEVER WENT INSIDE THE PATIENT'S BODY. GRABBED ANOTHER STENT OF THE SAME SIZE AND MODEL THEN COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224820 EXPRESS® LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046630750 0014519049

    Patients

    Seq Age Sex Outcome Treatment
    1