BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4093262 · Received September 16, 2014

    Report

    Report Number
    2031527-2014-00264
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. COMPUTED TOMOGRAPHY IMAGING WAS PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: THERE WERE NO MEDICAL DOCUMENTATION AND SUBOPTIMAL IMAGING STUDIES AVAILABLE FOR THIS REVIEW; MEDICAL RECORDS WERE DENIED. PRODUCT APPROPRIATENESS AND PATIENT CANDIDACY COULD NOT BE FULLY ASSESSED. PRODUCT USE WAS INCONGRUENT WITH THE IFU DUE TO: PLACEMENT OF A LEFT HYPOGASTRIC SNORKEL AT THE INDEX PROCEDURE AND, THE LCIA APPEARED TO BE 47 X 43 MM ONE MONTH POST INDEX, AND MIGHT HAVE BEEN GREATER THAN 23 MM IN DIAMETER AT INDEX. CAUTIONARY PRODUCT USE THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT WAS THE TWO-SIZE DIFFERENCE BETWEEN THE AORTIC EXTENSIONS AND THE BIFURCATED STENT. AT ONE MONTH POST INDEX, THERE WAS RADIOLOGICAL EVIDENCE OF ADEQUATE OVERLAP; PARTIAL STENT COLLAPSE; A SMALL, POSTERIOR ENDOLEAK 6 CM FROM THE SUPERIOR STENT MARGIN; AND, AN ENDOLEAK TYPE IB OF THE LEFT ILIAC ARTERY. TEN MONTH POST INDEX, THERE WAS A SMALL INTERVAL ANEURYSM SAC INCREASE OF BOTH, THE AORTA AND LCIA, WITH RADIOLOGICAL EVIDENCE OF A PROXIMAL ENDOLEAK TYPE IIIA, AND A POSSIBLE ENDOLEAK TYPE II, AND AN ENDOLEAK TYPE IB OF THE LCIA. THE STENT COLLAPSE AT THE BIFURCATION WAS ESSENTIALLY UNCHANGED, ALTHOUGH THERE WAS EVIDENCE OF A POSTERIOR STRUT PROTRUSION DUE TO REMODELING, BUT NO FRANK STRUT FRACTURE. THE SECONDARY PROCEDURE, PROCEDURAL SUCCESS OR FINAL PATIENT OUTCOME COULD NOT BE ASSESSED DUE TO LACK OF INFORMATION. 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, THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, CLINICAL ASSESSMENT INDICATED THE DEVICE USE WAS INCONGRUENT WITH IFU, WHICH MIGHT HAVE BEEN A FACTOR IN THIS EVENT.

    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 11 MONTHS POST IMPLANT OF A BIFURCATED DEVICE, TWO SUPRARENAL AORTIC EXTENSION AND ONE LIMB EXTENSION, AN ENDOLEAK WAS IDENTIFIED BETWEEN AN AORTIC EXTENSION AND THE BIFURCATED DEVICE. THE PHYSICIAN COIL-EMBOLIZED THE LEFT HYPOGASTRIC ARTERY AND EXTENDED INTO THE EXTERNAL ILIAC ARTERY. THE PHYSICIAN RELINED THE ENTIRE STENT GRAFT WITH A TRI-VASCULAR DEVICE. HOWEVER, GOOD SEAL WAS NOT OBTAINED WITH THE POLYMER RINGS IN THE PROXIMAL PORTION OF THE IMPLANTED STENT GRAFTS. THE PHYSICIAN THEN PLACED A COMPETITOR'S BALLOON EXPANDABLE STENT TO OBTAIN SEAL IN THE AORTIC NECK. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. ADDITIONAL NOTE: DURING THE INDEX PROCEDURE A VIABAHN BALLOON EXPANDABLE STENT WAS ALSO IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571406 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C100-O20 1047262-012

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention