BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 3921087 · Received July 9, 2014

    Report

    Report Number
    9612164-2014-00744
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: UNAPPROVED USE OF DEVICE (STENT IMPLANTED IN UPPER ARM OF PATIENT). INHERENT RISK OF PROCEDURE (STENT THROMBOSIS). DEFORMATION PROBLEM. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE NOT RETURNED FOR EVALUATION). RELATED TO OPERATIONAL CONTEXT (FRACTURE MAY HAVE OCCURRED DURING POST DILATION OF STENT). EVALUATION CONCLUSION: OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE (STENT IMPLANTED IN UPPER ARM OF PATIENT). KNOWN INHERENT RISK OF PROCEDURE (STENT THROMBOSIS). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (FRACTURE MAY HAVE OCCURRED DURING POST DILATION OF STENT). (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN DEPLOYED COMPLETE (SE) SELF EXPANDABLE STENT IN A PATIENT. THE STENT WAS DEPLOYED IN THE MID VENOUS FISTULA. IT WAS REPORTED THAT THE FISTULA WAS SEVERELY CALCIFIED WITH MODERATE TORTUOSITY AND 60% STENOSIS. IT WAS REPORTED THAT A STRUT OF THE STENT FRACTURED. IT WAS REPORTED THAT THE PHYSICIAN POST DILATED THE COMPLETE SE STENT WITH A HIGH PRESSURE CONQUEST BALLOON AND IT IS BELIEVED THAT IS WHEN THE STENT MAY HAVE STARTED TO FRACTURE. THE PATIENT PRESENTED WITH CLOT/STENT THROMBOSIS IN HIS FISTULA APPROXIMATELY 5 DAYS POST STENT IMPLANT AND THE PHYSICIAN CONFIRMED THE STENT WAS FRACTURED AND PLACED A COVERED STENT OVER THE MEDTRONIC STENT. NO OTHER CLINICAL SEQUELAE WERE REPORTED FOR THIS EVENT. IMAGE REVIEW: ONE STILL IMAGE WAS RECEIVED FOR REVIEW. REVIEW OF THE RETURNED IMAGE APPEARS TO SHOW THAT THE STENT MAY HAVE BEEN DAMAGED. THE MIDDLE SECTION OF THE STENT APPEARS TO HAVE BEEN SLIGHTLY CRUSHED AND DOES NOT APPEAR TO BE EXPANDED UNIFORMLY. THE IMAGE ALSO SHOWS THAT THE DEVICE WAS IMPLANTED INTO THE UPPER ARM OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400182 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND 0007069678

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention PLAVIX