BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4093332 · Received September 16, 2014

    Report

    Report Number
    2031527-2014-00274
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. MEDICAL RECORDS AND IMAGING WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: THERE WERE SUBOPTIMAL MEDICAL DOCUMENTATION AND IMAGING STUDIES AVAILABLE FOR THIS REVIEW. PRODUCT USE WAS INCONGRUENT WITH THE IFU AND MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT DUE TO: THE GREATER THAN 60 DEGREE ANGULATION OF THE AORTIC NECK (APPROXIMATELY 90 DEGREES). CAUTIONARY PRODUCT USE CONDITIONS WHICH MIGHT HAVE BEEN A CONTRIBUTING FACTOR WERE: THE THROMBUS AND CALCIFICATIONS AT THE AORTIC NECK; THE APPROXIMATELY 90 DEGREE LATERAL ANGULATION OF THE AORTIC BLOOD LUMEN; AND, THE HEAVILY CALCIFIED BILATERAL ILIAC ARTERIES. THE PATIENT'S HISTORY OF ANTICOAGULATION THERAPY INCREASED THEIR RISK FOR BLEEDING COMPLICATIONS (PERSISTENT ENDOLEAKS). BUT, PRO-THROMBIC CONDITIONS EXISTED, AND MIGHT HAVE CONTRIBUTED TO THE OCCLUSION OF THE RIGHT ILIAC ARTERY SUCH AS: PVD, CHF AND S/P BREAST CANCER. ENDOTENSION WAS EVIDENT OVER THE COURSE OF THE DEVICE DUE TO EARLY DETECTION OF BOTH THE PROXIMAL AND DISTAL ENDOLEAK AT TWO MONTHS POST IMPLANT. THE PATIENT WAS NOT A SURGICAL CANDIDATE, AND THE PROXIMAL LEAK WAS FELT TO BE UNREPAIRABLE. THE PATIENT WAS DENOTED TO BE UNDER HOSPICE CARE ((B)(6) 2014). THERE WAS SUBSTANTIATED EVIDENCE OF: A TYPE IA AND IB (RIGHT ILIAC) ENDOLEAK AT 2 MONTHS POST IMPLANT, WITH PROGRESSIVE ENDOTENSION. THESE CONDITIONS WERE NOT TREATED UNTIL THE PATIENT WAS READMITTED URGENTLY AN OCCLUSION OF THE LIMB PORTION OF THE MAIN BODY STENT AND A COMPLICATION OF A DISTAL OCCLUSION OF THE RIGHT COMMON FEMORAL ARTERY, 14 MONTHS POST IMPLANT. ALTHOUGH THE PATIENT WAS DISCHARGED ON POD 1, THEY WERE READMITTED ONCE AGAIN FOR ACUTE ISCHEMIA OF THE RIGHT LEG (COMPLICATION). THE RCFA WAS OCCLUDED AND A FEM-FEM BYPASS AND LEFT COMMON FEMORAL ARTERY ENDARTERECTOMY WAS PERFORMED TO RESTORE BLOOD FLOW. THE KNOWN TYPE IA ENDOLEAK STILL PERSISTED. THE FINAL PATIENT DISPOSITION WAS NOT KNOWN DUE TO LACK OF INFORMATION. BASED UPON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THIS EVENT IS MOST LIKELY DUE TO THE PATIENT'S ANATOMY AND EXISTING CONDITIONS. THE PATIENT'S USE OF ANTIPLATELET THERAPY MIGHT HAVE CONTRIBUTED TO THIS COMPLAINT DUE TO AN INCREASED RISK OF BLEEDING COMPLICATIONS. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO RELATED ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED THAT ALL UNITS WERE CONSUMED AND NO OTHER UNITS WERE INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING.

    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 REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 14 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND AN INFRARENAL AORTIC EXTENSION, A FOLLOW UP CT REVEALED PRESENCE OF A DISTAL ENDOLEAK OF THE RIGHT LIMB. THE PHYSICIAN EXTENDED THE RIGHT LIMB WITH A LIMB EXTENSION, WHICH RESOLVED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570899 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-80/I20-40 1101242-025

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention