BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4171768 · Received October 15, 2014

    Report

    Report Number
    2031527-2014-00291
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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: PRODUCT USE WAS INCONGRUENT WITH THE IFU DUE TO: THE SHORT AORTIC NECK OF 1.2 CM; THE RIGHT COMMON ILIAC ARTERY DIAMETER OF 3.0 CM. OTHER FACTORS THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT INCLUDED: THE PATIENT'S HISTORY OF ANTICOAGULATION THERAPY DUE TO ITS KNOWN, INCREASED RISK OF BLEEDING COMPLICATIONS; AND, THE PATIENT'S POSITIVE HISTORY OF CURRENT TOBACCO USE COULD HAVE CONTRIBUTED TO DISEASE PROGRESSION. THERE WAS SUBSTANTIATED EVIDENCE OF A PROGRESSIVE STENT SEPARATION, DESPITE ADEQUATE OVERLAP AT THE INITIAL PROCEDURE. OVERLAP WAS REDUCED TO 3.5 CM FROM 4.5 CM AT FIVE MONTHS POST IMPLANT. CONTRASTED SURVEILLANCE MIGHT NOT HAVE BEEN UTILIZED AS RECOMMENDED, WHICH MIGHT HAVE CONTRIBUTED TO THE EVENT. THE ULTRASOUND AT NINE MONTHS POST IMPLANT DID NOT DETECT AN ENDOLEAK, BUT THE SAC HAD INCREASED IN SIZE IN COMPARISON TO PRE- IMPLANT DATA; UNRESOLVED ENDOTENSION MIGHT HAVE BEEN A CONTRIBUTING FACTOR. 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 HAVE BEEN 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. BASED UPON THE INVESTIGATION FINDINGS, A ROOT CAUSE FOR THE REPORTED ENDOLEAK AND COMPONENT SEPARATION APPEARS TO BE THE RESULT OF STENT MIGRATION. THE PATIENT'S SHORT AORTIC NECK OF 1.2 CM IS OUTSIDE THE DEVICE USAGE GUIDELINES AND HAS THE POTENTIAL TO CONTRIBUTE TO STENT MIGRATION. THE PATIENT'S POSITIVE HISTORY OF CURRENT TOBACCO USE COULD HAVE CONTRIBUTED TO DISEASE PROGRESSION. THE EVALUATION DID NOT IDENTIFY A DEVICE SPECIFIC ISSUE.

    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 26.4 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, THE PATIENT PRESENTED EMERGENTLY AND COMPONENT SEPARATION WITH AN ENDOLEAK WAS DETECTED BETWEEN THE BIFURCATED DEVICE AND AORTIC EXTENSION. THE PHYSICIAN TREATED THE PATIENT WITH AN ADDITIONAL AORTIC EXTENSION, WHICH RESOLVED THE ENDOLEAK AND COMPONENT SEPARATION. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653720 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A28-28/C75-O20 1043313-005

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention