BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 2880603 · Received December 19, 2012

    Report

    Report Number
    2031527-2012-00170
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. ACTUAL DEVICE NOT RETURNED HENCE NO DEVICE EVALUATION PERFORMED. OPERATIVE NOTES AND COMPUTED TOMOGRAPHY SCANS WERE PROVIDED AND REVIEWED BY QUALITY AND CLINICAL REPRESENTATIVES. PER REVIEW, THE OPERATIVE NOTES STATE THAT THERE WAS STENOSIS, IN ADDITION TO CONSIDERABLE TORTUOSITY, IN THE COMMON ILIAC ARTERIES. THESE ANATOMICAL LIMITATIONS COMPLICATED THE DEVICE WITHDRAWAL, LEADING TO MANIPULATION BY THE USER, RESULTING IN THE REPORTED TIP SEPARATION. THE TIP WAS REMOVED WITH SNARE AND PROCEDURE CONCLUDED. THE INDICATIONS FOR USE PROVIDED IN THE INSTRUCTIONS FOR USE (IFU), CLEARLY SPECIFY THE APPROPRIATE COMMON ILIAC ARTERY DIMENSIONS. FURTHERMORE, THE IFU CONTAINS A SPECIFIC WARNING TO NOT APPLY EXCESSIVE FORCE DURING ADVANCEMENT OR WITHDRAWAL OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY (MEDWATCH # (B)(6)) THAT, "DURING DEPLOYMENT OF STENT, THE TIP OF INTRODUCER OR STENT DEPLOYMENT DEVICE HAD TO BE RETRIEVED BY SNARE. PIECE WAS SUCCESSFULLY REMOVED." ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT THE RADIOPAQUE TIP OF THE LIMB EXTENSION DELIVERY SYSTEM DETACHED DURING PROCEDURE. REPORTEDLY, WHEN THE PHYSICIAN DEPLOYED THE LIMB EXTENSION ON THE LEFT ILIAC, THE RADIOPAQUE TIP WAS CAUGHT ON THE DISTAL AORTA MAIN BODY DUE TO A 90 DEGREE ANGLE AT THE ILIAC. THE PHYSICIAN ROTATED THE DEVICE SEVERAL TIMES TO RELEASE THE TIP, BUT THE TIP WAS DETACHED FROM THE DELIVERY SYSTEM INSTEAD. THE PHYSICIAN USED A SNARE TO REMOVE THE TIP AND COMPLETED THE PROCEDURE WITHOUT FURTHER COMPLICATIONS. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFX SYSTEM LIMB EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. I16-16/C55F 1031325-009

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR