BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM

    MDR report key: 1912049 · Received December 1, 2010

    Report

    Report Number
    2134265-2010-05338
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED SO A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. 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 PERIPHERAL STENTING TREATMENT PROCEDURE, THE STENT MOVED ON THE BALLOON. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY AND A 6FR NON-BSC INTRODUCER SHEATH WAS INSERTED. THE 95% STENOSED LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS LEFT SUBCLAVIAN ARTERY. THE LESION WAS NOT PREDILATED. THE PHYSICIAN ADVANCED THE 8MM X 30MM X 75CM EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM AND DIFFICULTIES WERE ENCOUNTERED DUE TO "A LOT OF CALCIFICATION" NOTED ALONG THE WAY AND THE PATIENT'S "STEEP HEART." AS THE PHYSICIAN ATTEMPTED TO ADVANCE THE EXPRESS LD ACROSS THE LESION RESISTANCE WAS ENCOUNTERED AND THE STENT MOVED APPROXIMATELY 1-2MM ON THE BALLOON. THE EXPRESS LD STENT WAS PULLED BACK TO THE SHEATH, HOWEVER, THE PHYSICIAN WAS UNABLE TO REMOVE. THE PHYSICIAN ELECTED TO DEPLOY THE STENT IN THE ILIAC ARTERY. THE PHYSICIAN DID NOT COMPLETE THE PROCEDURE DUE TO THIS EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046830750 0013566877

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INTRODUCER SHEATH: 6F DESTINATION