BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 3840413 · Received May 30, 2014

    Report

    Report Number
    2031527-2014-00170
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT IS CONFIRMED BASED ON EXAMINATION OF THE RETURNED DEVICE THAT SHOWED THE RELEASE SLEEVE AND OUTER SHEATH TO BE HEAVILY DAMAGED. THE CLINICAL ASSESSMENT ALSO CONFIRMED THE REPORTED DIFFICULTY. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE. THE REVIEW INDICATES: SEVERE CALCIFICATIONS WERE SEEN THROUGHOUT THE SYSTEM, AND WERE PRESENT IN THE JUXA- AND INFRA- RENAL AREAS. THERE MIGHT HAVE BEEN PRODUCT USE THAT WAS INCONGRUENT WITH SIZING RECOMMENDATIONS: THE AORTIC CUFF WAS TWO SIZES BIGGER THAN THE MAIN BODY. THESE FINDINGS MIGHT HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED MALFUNCTION WAS DOCUMENTED COULD NOT BE SUBSTANTIATED BY MEDICAL RECORDS OR IMAGES. THE RETRACTION OF THE SLEEVE INTO THE SHEATH PRIOR TO THE IN-VIVO DEPLOYMENT, MIGHT HAVE CONTRIBUTED TO THIS EVENT. A MIGRATION DURING PROCEDURE MIGHT BETTER DESCRIBE THIS EVENT. THE COMPLICATION OF RENAL OCCLUSION AND INSUFFICIENCY WAS SUBSTANTIATED, AS WAS A SECONDARY PROCEDURE (TRANS-BRACHIAL STENT ATTEMPT). 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 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. THE ROOT CAUSE FOR THE REPORTED ISSUE IS INCONCLUSIVE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION OF A SUPRARENAL AORTIC EXTENSION, THE PHYSICIAN EXPERIENCED DEPLOYMENT DIFFICULTIES. REPORTEDLY, DURING DEPLOYMENT OF THE SUPRARENAL AORTIC EXTENSION, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER FIRST ROTATION OF THE DIAL AND THE EXTENSION WOULD NOT DEPLOY. THE PHYSICIAN CONTINUED TO ROTATE THE DIAL, AND THE WHITE RELEASE SLEEVE WOULD NOT RELEASE THE PROXIMAL PORTION OF THE AORTIC EXTENSION. THE PHYSICIAN WENT UP THROUGH THE CONTRALATERAL SIDE WITH A BALLOON AND BALLOONED UP TO THE TWO DISTAL SEGMENTS OF THE BIFURCATED STENT GRAFT. THEN BALLOON WAS PLACED BEYOND THE STENT MARKER AND ADVANCED THE 17 FR SHEATH AND THE AORTIC EXTENSION POPPED OPEN. A COMPUTED TOMOGRAPHY WAS PERFORMED, SHOWING THE AORTIC EXTENSION WAS IMPLANTED PARTIALLY COVERING THE RENAL ARTERIES. SEVERAL ATTEMPTS AND TROUBLESHOOTING WERE DONE, BUT ONLY ONE RENAL ARTERY WAS COMPLETELY UNBLOCKED. THE LEFT RENAL ARTERY REMAINED PARTIALLY BLOCKED BY APPROXIMATELY 3MM. THE PHYSICIAN ELECTED TO CONCLUDE THE PROCEDURE. THE PATIENT IS BEING MONITORED. ADDITIONAL NOTE: DURING DEVICE PREPARATION IT WAS INDICATED THAT AFTER FLUSHING THE DEVICE A FEW MM OF THE WHITE RELEASE SLEEVE PROTRUDED OUT OF THE DISTAL END. THIS WAS RESOLVED BY ADVANCING THE SHEATH BACK OVER THE EXPOSED MATERIAL. NOTHING ADDITIONAL WAS NOTICED DURING DEVICE PREPARATION. THE PATIENT'S DISTAL VESSELS WERE REPORTED TO BE STRAIGHT. PATIENT WAS REPORTED TO BE OF LARGE SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318465 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C80-O20V 1203550-001

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR