BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3881334 · Received June 18, 2014

    Report

    Report Number
    2031527-2014-00206
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 A STILL IMAGE WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: PRODUCT USE IN THIS FUSIFORM ANEURYSM MIGHT HAVE BEEN INCONGRUENT DUE TO CALCIFICATIONS AT THE INFRARENAL NECK; THORACIC ANEURYSM/PSEUDOANEURYSM; AND MULTIPLE PATENT LUMBAR ARTERIES. THE PATIENT'S ANTIPLATELET THERAPY MIGHT HAVE CONTRIBUTED TO THE REPORTED ISSUE DUE TO THE INCREASE RISK FOR BLEEDING. THE REPORTED ENDOLEAK TYPE IIIA WAS SUBSTANTIATED. ADDITIONALLY, ROUTINE CT SCAN AT 34 MONTHS POST INDEX SHOWED A LEFT SIDED ENDOLEAK OF 17.7 CM FROM SUPERIOR MARGIN OF THE STENT, WHICH MIGHT REPRESENT AN ENDOLEAK TYPE IIB. 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 THAT ALL UNITS HAVE BEEN CONSUMED AND NO OTHER UNITS FROM THE SAME LOT 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 REVIEW OF THE AVAILABLE INFORMATION, A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENTS COULD NOT BE SPECIFICALLY DETERMINED; HOWEVER, PATIENT ANATOMICAL FACTORS AND THERAPY TREATMENT MAY HAVE PLAYED A ROLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 34 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND AN INFRARENAL AORTIC EXTENSION, A COMPUTED TOMOGRAPHY SCAN REVEALED AN ENDOLEAK DUE TO COMPONENT JUNCTURE SEPARATION BETWEEN THE BIFURCATED DEVICE AND AORTIC EXTENSION. THE PHYSICIAN TREATED THE PATIENT WITH AN ADDITIONAL INFRARENAL AORTIC EXTENSION TO BRIDGE THE TWO COMPONENTS. FINAL ANGIOGRAM REVEALED GOOD RESULT AND THE ENDOLEAK WAS NO LONGER VISIBLE. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357639 AFX SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C80 W11-2846-002

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention