BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4210438 · Received October 29, 2014

    Report

    Report Number
    2031527-2014-00302
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 23, 2014
    Report Date
    October 13, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED WHEN IT WAS EXPLANTED AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. MEDICAL RECORDS AND IMAGING WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: THE REPORTED EVENT HAS BEEN CONFIRMED. THE EXPLANTED DEVICES WERE NOT AVAILABLE FOR ANALYSIS. PRODUCT USE WAS INCONGRUENT WITH THE IFU DUE TO: THE NATURAL BIFURCATION DIAMETER OF 14-15 MM AND THE RESULTANT ~ 7.0 MM DIAMETER DUE TO THE PRE-EXISTING LEFT ILIAC STENT AT THIS LEVEL; AND, BILATERAL ILIAC ARTERY DIAMETERS APPROXIMATELY 8.0 MM DUE TO PRE-EXISTING STENTS. CAUTIONARY PRODUCT USE CONDITIONS THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT INCLUDED: MODERATELY CALCIFIED BIFURCATION AND AN ABDOMINAL ANEURYSM OF LESS THAN 5.0 CM. THE PATIENT'S HISTORY OF CHF, S/P PROSTATE CANCER, AND PVD MIGHT HAVE CONTRIBUTED TO THIS COMPLAINT DUE TO THEIR INCREASED RISK OF THROMBUS FORMATION. THE SUPERIOR MARGIN OF THE PRE-EXISTING LEFT ILIAC STENT WAS WITHIN THE DISTAL AORTA, SLIGHTLY ABOVE THE NATURAL BIFURCATION, WHICH MIGHT HAVE CONTRIBUTED TO THE EVENTUAL OCCLUSIONS. A MANUFACTURING RECORD REVIEW WAS PERFORMED. THE LOT MET ALL RELEASE CRITERIA WITH NO RELATED DEVIATIONS. THE LOT USAGE HISTORY SHOWS THAT NO OTHER UNITS FROM THIS LOT HAVE BEEN INVOLVED IN ANY SIMILAR COMPLAINTS AT THIS TIME. THE PRODUCT LABELING HAS BEEN REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. BASED UPON THE INVESTIGATION FINDINGS, THE ROOT CAUSE HAS BEEN DETERMINED TO BE DUE TO PATIENT'S ANATOMY AND CONDITION; OFF-LABEL USE OF THE DEVICE IN A NON-ANEURYSMAL AORTA; PREVIOUS ENDOVASCULAR TREATMENT OF ILIACS; AND, POSSIBLY DUE TO PLACEMENT OF THE PRE-EXISTING LEFT ILIAC STENT WITHIN THE DISTAL AORTA.

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE NOT RETAINED DURING EXPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED APPROXIMATELY 1 MONTH POST IMPLANT OF A BIFURCATED DEVICE THE PATIENT SUFFERED PROXIMAL MIGRATION AND GRAFT THROMBOSIS WITH BILATERAL LIMB ISCHEMIA. THE DISTAL NECK WAS TOO SMALL AND BOTH LIMBS WERE COMPRESSED. ON (B)(6) 2014 ANOTHER PHYSICIAN ELECTED TO PERFORM A SECONDARY PROCEDURE WHERE AN EXPLANT CONVERSION TO CONVENTIONAL REPAIR WAS DONE. PHYSICIAN REMOVED THE BIFURCATED DEVICE, THE COMPETITOR BARE METAL EXTERNAL ILIAC STENTS AND A FAILED FEM-FEM BYPASS. OF ADDED NOTE, NOT REALIZED UNTIL AFTER OPERATIVE CULTURES WERE DONE, THE GRAFT WAS ALSO INFECTED. THE BIFURCATED DEVICE WAS NOT RETAINED DURING THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692132 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-80/I13-40 1136124-015

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention