BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS® LD ILIAC / BILIARY

    MDR report key: 2840503 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07085
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND VISUAL EXAMINATION REVEALED NO ISSUES WITH THE DEVICE. THERE WERE NO KINKS ALONG THE LENGTH OF THE SHAFT AND EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES WITH ITS PROFILE. THERE WAS NO DAMAGE VISIBLE ON THE STENT. AS A RESULT OF THE 7 FRENCH INTRODUCER SHEATH NOT BEING RETURNED WITH THE DEVICE FOR ANALYSIS, THE DEVICE WAS INSERTED THROUGH OUR OWN RECOMMENDED SIZE 6 FRENCH SHEATH AND THE DEVICE PASSED THROUGH THE SHEATH WITH NO RESTRICTIONS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTION PROCEDURE, STENT DAMAGE OCCURRED. LESION DETAILS ARE UNKNOWN. IT WAS NOTICED THAT THIS 8.0 X 20 X 135CM EXPRESS B-I LD PMTD STENT APPEARED TO BE "CRIMPED DOWN" WHEN REMOVING FROM THE BOX. THE EXPRESS LD WAS NOT ABLE TO ADVANCE THROUGH THE UNKNOWN 7FR SHEATH DUE TO THE STENT BEING CRIMPED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME EXPRESS LD STENTS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTION PROCEDURE, STENT DAMAGE OCCURRED. LESION DETAILS ARE UNKNOWN. IT WAS NOTICED THAT THIS 8.0 X 20 X 135CM EXPRESS B-I LD PMTD STENT APPEARED TO BE "CRIMPED DOWN" WHEN REMOVING FROM THE BOX. THE EXPRESS LD WAS NOT ABLE TO ADVANCE THROUGH THE UNKNOWN 7FR SHEATH DUE TO THE STENT BEING CRIMPED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME EXPRESS LD STENTS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTION PROCEDURE, STENT DAMAGE OCCURRED. LESION DETAILS ARE UNKNOWN. IT WAS NOTICED THAT THIS 8.0 X 20 X 135CM EXPRESS B-I LD PMTD STENT APPEARED TO BE "CRIMPED DOWN" WHEN REMOVING FROM THE BOX. THE EXPRESS LD WAS NOT ABLE TO ADVANCE THROUGH THE UNKNOWN 7FR SHEATH DUE TO THE STENT BEING CRIMPED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME EXPRESS LD STENTS. 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 H74938047820130 0015267704

    Patients

    Seq Age Sex Outcome Treatment
    1