BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS® LD ILIAC / BILIARY

    MDR report key: 2870330 · Received December 12, 2012

    Report

    Report Number
    2134265-2012-07775
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE 9.0X60X75CM EXPRESS LD ILIAC / BILIARY STENT DELIVERY SYSTEM (SDS) WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. HOWEVER DURING WITHDRAWAL OF THE EXPRESS LD SDS THE DEVICE WOULD NOT COME BACK THROUGH THE 7FR SHEATH. AS A RESULT, THE SDS AND THE 7F SHEATH WERE REMOVED TOGETHER AS ONE UNIT. VASCULAR ACCESS WAS OBTAINED WITH ANOTHER SHEATH AND THE PROCEDURE WAS COMPLETED. THE COMPLAINT WOULD NOT BE CONSIDERED A REPORTABLE EVENT.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2012-07774. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, DIFFICULTY REMOVING A CATHETER OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 9.0X60X75CM EXPRESS LD ILIAC / BILIARY STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND POSITIONED AT THE TARGET LESION. THE STENT WAS NOT DEPLOYED AND THE PHYSICIAN ELECTED TO REMOVE THE DEVICE. HOWEVER, DURING WITHDRAWAL, THE SDS WOULD NOT COME BACK THROUGH THE 7FR SHEATH. THE SDS AND THE 7FR SHEATH HAD TO BE REMOVED TOGETHER AS ONE UNIT. A 9.0X40X75CM EXPRESS LD ILIAC / BILIARY STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND POSITIONED AT THE TARGET LESION. THE STENT WAS NOT DEPLOYED AND THE PHYSICIAN ELECTED TO REMOVE THE DEVICE. HOWEVER, DURING WITHDRAWAL, THE SDS WOULD NOT COME BACK THROUGH THE 7FR SHEATH. THE SDS AND THE 7FR SHEATH HAD TO BE REMOVED TOGETHER AS ONE UNIT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED U.S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS® LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046940750 15149787

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT, 9.0X60X75CM EXPRESS LD