BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS® LD ILIAC / BILIARY

    MDR report key: 2944433 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00344
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED THE SHAFT WAS BROKEN PROXIMAL TO THE PROXIMAL BALLOON SLEEVE. THERE WAS EVIDENCE OF SEVERE STRETCHING AT THE BREAK SITE. EXAMINATION OF THE BALLOON MATERIAL NOTED THAT IT WAS DEFLATED BUT NOT CORRECTLY WRAPPED. A VISUAL AND TACTILE EXAMINATION OF THE REMAINDER OF THE SHAFT NOTED SLIGHT KINKS ALONG ITS LENGTH. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE DIFFICULTY REMOVING AND BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT ILIAC ARTERY. A 9.0X60X75CM EXPRESS LD ILIAC / BILIARY STENT DELIVERY SYSTEM (SDS) WAS SUCCESSFULLY ADVANCED AND THE STENT WAS DEPLOYED. FOR POST DILATION, THE SDS BALLOON WAS THEN INFLATED AND DEFLATED. AS THE SDS WAS WITHDRAWN INTO THE 7F NON BSC SHEATH RESISTANCE WAS FELT AND THE BALLOON DETACHED FROM THE SDS. THE SDS WAS WITHDRAWN; HOWEVER, THE BALLOON DETACHED AND REMAINED PROTRUDING FROM THE SHEATH HALFWAY INTO THE BODY. UNDER FLUOROSCOPY, IT WAS NOTED THAT THE BALLOON MARKERS WERE ONE INSIDE THE SHEATH AND ONE OUTSIDE THE SHEATH. THE PHYSICIAN PULLED A HARD NEGATIVE ON THE SHEATH TO CREATE A VACUUM AND REMOVED THE INTRODUCER SHEATH AND THE DETACHED BALLOON TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48548 EXPRESS® LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046960750 0015056219

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other INTRODUCER SHEATH, TERUMO 7F