BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 3728558 · Received April 7, 2014

    Report

    Report Number
    2031527-2014-00110
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 A CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: THE REPORTED PROXIMAL ENDOLEAK COULD NOT BE IDENTIFIED, ALTHOUGH ANEURYSMAL DISEASE PROGRESSION AND A POSSIBLE TYPE II ENDOLEAK MIGHT HAVE BEEN CONTRIBUTING FACTORS. THE INVESTIGATION DID NOT IDENTIFY A DEVICE ISSUE. 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 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. (B)(4).

    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 RETAINED AT USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 21 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND AN SUPRARENAL AORTIC EXTENSION, A ROUTINE COMPUTED TOMOGRAPHY SCAN REVEALED A PROXIMAL ENDOLEAK. REPORTEDLY, THE PHYSICIAN ELECTED TO BRING THE PATIENT BACK WITHIN A MONTH OF THE FINDING TO TREAT THE ENDOLEAK. A MONTH LATER, THE PATIENT WAS BROUGHT BACK, AND A SUPRARENAL AORTIC EXTENSION WAS IMPLANTED. THE PHYSICIAN POST-DILATED THE AORTIC EXTENSION, IN AN ATTEMPT TO FURTHER OPPOSE THE STENT GRAFT TO THE AORTIC WALLS, HOWEVER, THIS DID NOT RESOLVE THE ENDOLEAK. THE PATIENT HAS A SHORT AORTIC NECK (APPROXIMATELY 11MM), AND ANGULATED. THE PATIENT IS BEING MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 20 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND AN SUPRARENAL AORTIC EXTENSION, A ROUTINE COMPUTED TOMOGRAPHY SCAN REVEALED A PROXIMAL ENDOLEAK. REPORTEDLY, THE PHYSICIAN ELECTED TO BRING THE PATIENT BACK WITHIN A MONTH OF THE FINDING TO TREAT THE ENDOLEAK. THE PHYSICIAN IS MONITORING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209255 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT (SCS) MIH ENDOLOGIX, INC. A34-34/C100-O20 W11-4940-010

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention