BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 4240504 · Received November 10, 2014

    Report

    Report Number
    2031527-2014-00322
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 APPROPRIATENESS ASSESSMENTS WERE LIMITED DUE TO THE LACK OF A PRE IMPLANT CT SCAN. USING THE PRE IMPLANT ANGIOGRAM FOR THE ASSESSMENT, PRODUCT USE MIGHT HAVE BEEN INCONGRUENT WITH THE IFU DUE TO: APPROX. 65 DEGREE AORTIC NECK ANGULATION, AND GREATER THAN 90 DEGREE ANGULATION OF THE LEFT COMMON ILIAC ARTERY. CAUTIONARY PRODUCT USE THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT INCLUDED: THE RUPTURED STATE OF THE ANEURYSM; THE PATIENT'S INABILITY TO TOLERATE CONTRASTED SURVEILLANCE, PRESUMABLY DUE TO THE PRESENCE OF DIABETES; AND, THE PATIENT'S USE OF ANTIPLATELET THERAPY, DUE TO THE INCREASE RISK FOR BLEEDING COMPLICATIONS. GIVEN THE LONGEVITY OF THE DEVICE, DISEASE PROGRESSION AND/OR AORTIC REMODELING MIGHT HAVE ALSO CONTRIBUTED TO THIS EVENT. THE ENDOLEAK TYPE IB WAS SUBSTANTIATED. ALTHOUGH THE PATIENT WAS BEING TREATED FOR A SYSTEMIC INFECTION AND THEY SUSTAINED MULTIPLE FALLS, THE STENT GRAFT APPEARED TO BE UNAFFECTED BY THESE INCIDENCES. THE PATIENT WAS ON ANTICOAGULATION (LOVENOX) TWO WEEKS PRIOR TO THE LAST KNOWN CT SCAN AND READMISSION; THE ADMISSION DIAGNOSIS WAS RESPIRATORY FAILURE DUE TO HYPOVOLEMIC SHOCK, AND ANEMIA STATUS POST WOUND DEBRIDEMENT, NOT AN ENDOLEAK. THERE WAS NO EVIDENCE TO SUPPORT THAT THE ENDOLEAK WAS TREATED AT THAT TIME. NON TREATMENT WAS CONFIRMED. 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 HAVE BEEN CONSUMED AND NO OTHER UNITS FROM THIS LOT 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, A ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DEFINITELY IDENTIFIED ALTHOUGH THE CLINICAL REVIEW SUGGESTS THAT THERE WERE A NUMBER OF PATIENT ISSUES THAT WERE LIKELY CONTRIBUTORS INCLUDING THE RUPTURED STATE OF THE ANEURYSM, THE APPROXIMATELY 65 DEGREE AORTIC NECK ANGULATION, THE GREATER THAN 90 DEGREE ANGULATION OF THE LEFT COMMON ILIAC ARTERY, AND THE PATIENT'S USE OF ANTIPLATELET THERAPY. NO SPECIFIC DEVICE PROBLEM WAS IDENTIFIED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 29 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, A LEFT DISTAL ENDOLEAK WAS IDENTIFIED IN COMPUTED TOMOGRAPHY SCAN DURING A ROUTINE VISIT. THE PHYSICIAN IS MONITORING THE PATIENT AND HAS PLANS TO PERFORM AN INTERVENTION IN NOVEMBER THIS YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723456 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-90/I16-30 1031315-021

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR