BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS (TM) LD VASCULAR

    MDR report key: 2211471 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03293
    Event Type
    Injury
    Date Received
    August 15, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: ANALYSIS OF THE RETURNED DEVICE REVEALED THE STENT WAS RECEIVED SEPARATELY FROM DELIVERY DEVICE. VISUAL AND TACTILE EXAMINATION OF THE DEVICE REVEALED NO DAMAGE WAS NOTED TO THE SHAFT OF THE DEVICE. THE BALLOON WAS FOLDED AND WRAPPED FULLY AROUND THE SHAFT OF THE DEVICE. A CLEAR IMPRESSION OF WHERE THE STENT WAS ORIGINALLY CRIMPED WAS VISIBLE ON THE BALLOON MATERIAL. THE DISTAL END OF THE BALLOON APPEARED TO BE SLIGHTLY BUNCHED. VISUAL AND MICROSCOPIC INSPECTION EXAMINATION OF THE STENT REVEALED THE STENT WAS FLATTENED AND DAMAGED ALONG ITS LENGTH. THE STRUTS ON ONE END OF THE STENT WERE BENT IN AND LIFTED UP. SOME OF THE STRUTS WERE MISALIGNED. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. THE TARGET LESION DETAILS ARE UNKNOWN. THE PHYSICIAN ADVANCED THE 9.0MMX60MM EXPRESS LD VASCULAR STENT SYSTEM. AT AN UNSPECIFIED TIME, THE STENT SYSTEM WAS WITHDRAWN AND IT WAS NOTED, "THEY WERE MISSING THE STENT AT THE MONITOR". THE STENT WAS FOUND AT THE END OF THE SHEATH AND THEY WERE ABLE TO REMOVE IT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. NO ADDITIONAL INFORMATION AVAILABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. THE TARGET LESION DETAILS ARE UNKNOWN. THE PHYSICIAN ADVANCED THE 9.0MMX60MM EXPRESS LD VASCULAR STENT SYSTEM. AT AN UNSPECIFIED TIME, THE STENT SYSTEM WAS WITHDRAWN AND IT WAS NOTED, "THEY WERE MISSING THE STENT AT THE MONITOR". THE STENT WAS FOUND AT THE END OF THE SHEATH AND THEY WERE ABLE TO REMOVE IT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. NO ADDITIONAL INFORMATION AVAILABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS (TM) LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74938162960750 0014265985

    Patients

    Seq Age Sex Outcome Treatment
    1 Other