BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4210439 · Received October 29, 2014

    Report

    Report Number
    2031527-2014-00303
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 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

    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 IMAGING WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: PRODUCT USE WAS INCONGRUENT WITH THE IFU DUE TO: THE GREATER THAN 60 AORTIC NECK. CAUTIONARY PRODUCT USE CONDITIONS INCLUDED AN IMPENDING RUPTURE STATE OF THE ANEURYSM; JETTING CALCIFICATIONS AT THE BIFURCATION; AND, A CONCOMITANT THORACIC ANEURYSM. THE PATIENT'S USE OF ANTIPLATELET THERAPY MIGHT HAVE CONTRIBUTED TO THIS EVENT DUE TO THE ASSOCIATED INCREASE RISK FOR BLEEDING COMPLICATIONS. GIVEN THE LONGEVITY OF THE DEVICE AND THE PATIENT'S MEDICAL HISTORY, THERE MIGHT HAVE BEEN DISEASE PROGRESSION AND/OR UNRESOLVED ENDOTENSION THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT. THE ENDOLEAK TYPE III AND THE SECONDARY PROCEDURE WERE SUBSTANTIATED BY MEDICAL DOCUMENTATION; HOWEVER, SPECIFICALLY, A TYPE IIIB COULD NOT BE SUBSTANTIATED. MEDICAL DOCUMENTATION MENTIONED A TYPE I AND II AT THE IMPLANT PROCEDURE, BUT COULD NOT BE SUBSTANTIATED DUE TO LACK OF INFORMATION. THE PATIENT WAS DISCHARGED TO REHABILITATION POST-OPERATIVE DAY SEVEN. 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 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, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. HOWEVER, THE USE OF A DEVICE IN A GREATER THAN 60 DEGREE ANGLE (OFF-LABEL) MIGHT HAVE CONTRIBUTED TO THIS EVENT ALONG WITH THE PATIENT'S USE OF ANTIPLATELET THERAPY DUE TO THE ASSOCIATED INCREASE RISK FOR BLEEDING COMPLICATIONS. GIVEN THE LONGEVITY OF THE DEVICE AND THE PATIENT'S MEDICAL HISTORY, THERE MIGHT HAVE BEEN DISEASE PROGRESSION AND/OR UNRESOLVED ENDOTENSION THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 37 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION AN ENDOLEAK WAS IDENTIFIED. THE PATIENT HAD A CT AND PHYSICIAN ELECTED TO RELINE THE OVERLAP WITH 2 CUFFS. PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692499 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A25-25/C95-O20 W11-2908-022

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention