BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 3855088 · Received June 9, 2014

    Report

    Report Number
    2031527-2014-00185
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    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: PRODUCT USE MIGHT HAVE BEEN INCONGRUENT WITH THE IFU AND SIZING RECOMMENDATIONS DUE TO: THE AORTIC EXTENSION WAS TWO SIZES BIGGER IN DIAMETER THAN THE BIFURCATED DEVICE; THE INFRARENAL NECK WAS GREATER THAN 32 MM IN DIAMETER; BILATERAL ILIAC ARTERIES WERE TORTUOUS AND CALCIFIED; THE PATIENT'S HISTORY OF CHRONIC RENAL FAILURE. NON-CONTRASTED SURVEILLANCE MIGHT HAVE CONTRIBUTED TO THIS REPORTED EVENT AS THE STENTS WERE BEGINNING TO REMODEL SIX MONTHS POST INDEX; THE REPORTED MAIN BODY STENT COLLAPSE /KINK WAS NOT TREATED AT THAT TIME. THERE WAS EVIDENCE OF COMPLETE SEPARATION AT 12 MONTHS; THERE WAS NO EVIDENCE OF ACKNOWLEDGEMENT OR TREATMENT OF THIS CONDITION. THE RESULTANT DELAY IN CARE, ALONG WITH A HISTORY OF CANCER, ANEMIA AND DIABETES MIGHT HAVE CONTRIBUTED TO THE TOTAL OCCLUSION OF THE INFRARENAL AORTA. THE PRESUMED (B)(6) AORTIC REMODELING, MIGHT HAVE CONTRIBUTED TO THIS OUTCOME. THERE WAS SUBSTANTIAL RADIOLOGICAL EVIDENCE TO SUPPORT AN INITIAL (BUT LATER RESOLVED) STENT GRAFT COLLAPSE OF THE AORTIC EXTENSION, SUBSEQUENT COLLAPSE/KINK OF THE BIFURCATED DEVICE SEEN AT SIX MONTHS, AND THE STENT GRAFTS SEPARATION SEEN AT 12 MONTHS POST INDEX. A BIFURCATED DEVICE MAIN BODY AND LIMB STENT OCCLUSION WAS SUBSTANTIATED; OCCLUSION OF THE COMMON FEMORAL ARTERIES (COMPLICATION) WAS DOCUMENTED, BUT NOT DEMONSTRATED RADIOGRAPHICALLY. NO TREATMENT WAS SUBSTANTIATED. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED ALL UNITS WERE CONSUMED AND NO UNITS HAVE BEEN INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE REPORTED EVENT IS DETERMINED TO BE RELATED TO THE PATIENT'S ANATOMY THAT WAS INCONGRUENT WITH IFU INSTRUCTIONS. FAILURE TO EARLY DETECT AND TREAT THE EFFECTS OF VESSEL REMODELING LIKELY CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 21 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND AN SUPRARENAL AORTIC EXTENSION, THE PATIENT PRESENTED EMERGENTLY WITH LEFT LEG PAIN. AN X-RAY SHOWED BIFURCATED TO PROXIMAL CUFF SEPARATION. REMODELING OF THE ANEURYSM WAS PUSHING DOWN THE BIFURCATED DEVICE, CAUSING KINKING OF THE BIFURCATED LEFT LIMB AND OCCLUSION IN THAT LIMB. THE PHYSICIAN WILL BRING THE PATIENT BACK TO PERFORM AN ANGIOGRAM AND DETERMINE COURSE OF ACTION. ADDITIONAL NOTE: PATIENT HAD BEEN LOST FOR FOLLOW UP FOR THE LAST 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335772 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-90/I16-30 1033368-006

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR