BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3855139 · Received June 9, 2014

    Report

    Report Number
    2031527-2014-00175
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 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

    BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED TYPE IIIA ENDOLEAK WAS CONFIRMED BASED ON CLINICAL ASSESSMENT IMAGE REVIEW. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED THAT 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 UPON THE INVESTIGATION FINDINGS, A ROOT CAUSE FOR THE REPORTED TYPE IIIA ENDOLEAK COULD NOT BE DETERMINED. THE RETURNED DEVICE HAD NO APPARENT LEAK POINTS WHERE THE DEVICES OVERLAPPED EVEN THOUGH THE CLINICAL REVIEW DID CONFIRM A TYPE IIIA LEAK. THE DEVICE USAGE WAS FOUND TO BE OUTSIDE THOSE DESCRIBED IN THE IFU: THE SIZING; ANGULATION AND ANEURYSMAL AORTIC NECK; AND USE FOR TREATMENT OF A RUPTURED ABDOMINAL ANEURYSM. SECONDARY ANGULATION RELATED TO REMODELING WAS SEEN IN THE CLINICAL ASSESSMENT.

    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 5.4 MONTHS POST IMPLANT OF A BIFURCATED DEVICE, A SUPRARENAL AORTIC EXTENSION AND TWO LIMB EXTENSIONS, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REVEALED AN ENDOLEAK BETWEEN THE SUPRARENAL AORTIC EXTENSION AND BIFURCATED DEVICE. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL SUPRARENAL AORTIC EXTENSION, WHICH RESOLVED THE ENDOLEAK. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL.

    Description of Event or Problem · 1

    DURING FOLLOW UP VISIT A CT PERFORMED SHOWED AORTIC-ENTERIC FISTULA. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY EXPLANTING THE DEVICES AND PERFORMING OPEN REPAIR. THE PATIENT DID WELL DURING THE SECONDARY PROCEDURE AND IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334618 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C100-O20 1056065-029

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention