BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS (R) LD ILIAC / BILIARY

    MDR report key: 2434892 · Received February 1, 2012

    Report

    Report Number
    2134265-2012-00192
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 4, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING THE DEVICE PRIOR TO AN ILIAC INTERVENTION TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. THE 8.0X60X75CM EXPRESS-B-I LD STENT DELIVERY SYSTEM WAS PULLED OUT OF THE LOOP. THE STENT CAME OFF THE BALLOON WHEN THE PROTECTIVE SHEATH WAS REMOVED. IT WAS NOTED THAT PROTECTIVE SHEATH COVERING THE BALLOON WAS PULLED ROUGHLY. THE DEVICE DID NOT ENTER THE PATIENT. THE PROCEDURE WAS CONTINUED WITH ANOTHER EXPRESS B-ILD STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS (R) LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046860750

    Patients

    Seq Age Sex Outcome Treatment
    1