BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINK SYSTEM

    MDR report key: 4171685 · Received October 15, 2014

    Report

    Report Number
    2031527-2014-00308
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 AN INTERNAL CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: THERE WERE SUBOPTIMAL MEDICAL DOCUMENTATION AND IMAGING STUDIES AVAILABLE FOR THIS REVIEW. PRODUCT APPROPRIATENESS AND PATIENT CANDIDACY COULD NOT BE FULLY ASSESSED DUE TO THE LACK OF A PRE IMPLANT CT SCAN. HOWEVER, IT WAS NOTED THAT THE LCIA WAS 3.0 CM AT 29 MONTHS POST IMPLANT, WHICH MIGHT HAVE INDICATED PRODUCT USE THAT WAS INCONGRUENT WITH THE IFU. GIVEN THERE WAS A TWO-SIZE DIAMETER DIFFERENCE BETWEEN THE AORTIC EXTENSION AND BIFURCATED MAIN BODY STENT DIAMETERS, THE LONGEVITY OF THE DEVICE, AND THE PATIENT'S MEDICAL HISTORY, AORTIC REMODELING AND/OR DISEASE PROGRESSION MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT. DESPITE ADEQUATE STENT OVERLAP AT IMPLANT, AND THE USE OF BOTH ANTIPLATELET AND ANTICOAGULATION THERAPY, A PARTIAL OCCLUSION OF THE MAIN BODY STENT WAS CONFIRMED, AS WELL AS A PARTIAL STENT COLLAPSE AT THE BIFURCATION, AND A COMPLETE STENT SEPARATION WITHOUT AN ENDOLEAK AT 29 MONTHS POST IMPLANT. THE TYPE IIIA ENDOLEAK AND COMPLETE COMPONENT SEPARATION WAS SUBSTANTIATED AT 47 MONTHS POST IMPLANT; THE NON-TREATMENT AND/OR RECOGNITION OF THE STENT SEPARATION AT 18 MONTHS PRIOR, MIGHT HAVE CONTRIBUTED TO THE OUTCOME. 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 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 ENDOLEAK COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, PATIENT CONDITION MIGHT HAVE BEEN A CONTRIBUTING FACTOR.

    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

    T WAS REPORTED THAT APPROXIMATELY 46 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, A SUPRARENAL AORTIC EXTENSION AND A LIMB EXTENSION, AN ENDOLEAK BETWEEN THE BIFURCATED DEVICE AND THE SUPRARENAL EXTENSION WAS IDENTIFIED PER CT SCAN. THE PHYSICIAN HAS PLANS TO PERFORM A SECONDARY PROCEDURE AND TREAT THE PATIENT WITH AN AUI DEVICE AND A FEM-BY-FEM BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653563 POWERLINK SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 34-34-120RLE W10-2815-007

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR