BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC ILIAC¿

    MDR report key: 2920068 · Received January 17, 2013

    Report

    Report Number
    2134265-2013-00493
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIO
    PMA / PMN Number
    P110035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    (B)(4) STENT PLACEMENT. IT WAS REPORTED THAT DURING AN EXTERNAL ILIAC STENTING PLACEMENT PROCEDURE, THERE WAS DIFFICULTY REMOVING THE STENT CATHETER. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS APPROXIMATELY 90-99% STENOSED AND LOCATED IN THE SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. THIS EPIC ILIAC SELF-EXPANDING STENT DEVICE WAS ADVANCED AND THE PHYSICIAN NOTED THAT THE "STENT WAS PINCHED AT THE LESION LOCATION MAKING IT DIFFICULT TO PULL THE STENT CATHETER OUT". THE STENT WAS IMPLANTED BUT IT WAS NOTED THAT "THE REMOVAL WAS VERY DIFFICULT DUE TO THE STENOSIS" AND IT WAS REMOVED WITH SOME FORCE. THE LESION WAS NOT PRE-DILATED. AND SUCCESSFULLY IMPLANTED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS EPIC SELF-EXPANDING STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25983 EPIC ILIAC¿ STENT, ILIAC NIO BOSTON SCIENTIFIC - MAPLE GROVE UNK733

    Patients

    Seq Age Sex Outcome Treatment
    1