BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4233621 · Received November 6, 2014

    Report

    Report Number
    2031527-2014-00320
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED EVENT IS INCONCLUSIVE BASED ON CLINICAL ASSESSMENT OF PROVIDED MEDICAL RECORDS AND IMAGING STUDIES. THERE WERE ADEQUATE MEDICAL DOCUMENTATION AND IMAGING STUDIES AVAILABLE FOR THIS REVIEW. THE IMAGES COULD NOT BE MANIPULATED DUE TO THE LIMITATION OF THE VENDOR'S SOFTWARE (READ ONLY), WHICH LIMITED THE SENSITIVITY OF THE ASSESSMENT. PRODUCT USE WAS INCONGRUENT DUE TO: AORTIC NECK LENGTH OF LESS THAN 15MM; AORTIC NECK ANGULATION GREATER THAN 60 DEGREES; AND THE LEFT ILIAC ARTERY ANGULATION OF GREATER THAN 90 DEGREES. CAUTIONARY PRODUCT USE THAT MIGHT HAVE CONTRIBUTED TO THIS COMPLAINT INCLUDED: THE RUPTURED STATE OF THE ANEURYSM; THE CONCOMITANT ASCENDING THORACIC ANEURYSM; THE USE OF ANTICOAGULATION DUE TO THE INCREASED RISK OF BLEEDING COMPLICATIONS. THE PATIENT'S MEDICAL HISTORY REVEALED A FRAIL STATE OF HEALTH AND MANY ADMISSIONS RELATED TO THE END STAGE RESPIRATORY FAILURE, PRO-THROMBIC CONDITIONS, SUCH AS PULMONARY EMBOLI AND DEEP VEIN THROMBUS AS WELL AS SEPSIS AS RELATED TO LEG CELLULITIS. THERE WAS SUBSTANTIATED EVIDENCE OF A SUPRARENAL CROWN SEPARATION (STENT GRAFT FRACTURE) ASSOCIATED WITH CUFF DILATION SEEN AT SEVEN MONTHS POST IMPLANT. THE TYPE I-A ENDOLEAK WAS SUBSTANTIATED IN MEDICAL DOCUMENTATION, BUT WAS NOT WELL DEMONSTRATED RADIOGRAPHICALLY. 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 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. BASED UPON THE INVESTIGATION FINDINGS, ROOT CAUSE FOR THE ENDOLEAK COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE PATIENT'S PRE-EXISTING CONDITION AND ANATOMY ARE LIKELY CONTRIBUTING FACTORS.

    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 12 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, A COMPUTED TOMOGRAPHY DISPLAYED AN ENDOLEAK. REPORTEDLY, A CT WAS DONE 8 MONTHS AGO AND DISPLAYED AN ENDOLEAK. HOWEVER, THE PATIENT CAME IN (B)(6) 2014 TO SEAL THE ENDOLEAK AND CT SHOWED SUPRARENAL STRUTS FROM THE AORTIC EXTENSION HAVE SEPARATED FROM THE SUPRARENAL BODY. THE PHYSICIAN ELECTED TO RELINE WITH A SUPRARENAL AORTIC EXTENSION AND RESOLVED THE ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715396 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C100-O20 1047262-014

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention