BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 3821660 · Received May 20, 2014

    Report

    Report Number
    2031527-2014-00150
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 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. COMPUTER TOMOGRAPHY IMAGING WAS PROVIDED AND REVIEWED BY A CLINICAL REPRESENTATIVE WITH THIS IMPRESSION: GIVEN THE LONGEVITY OF THIS DEVICE, NEGATIVE REMODELING MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WAS AN APPARENT SECONDARY PROCEDURE INVOLVING A LUMBAR EMBOLIZATION. THERE MIGHT HAVE BEEN EVIDENCE OF CONTINUED LUMBAR ARTERIAL COMMUNICATION WITH THE SAC; THIS FINDING MIGHT HAVE BEEN A CONTRIBUTING FACTOR. THERE MIGHT HAVE BEEN EVIDENCE OF A PROXIMAL TYPE III-A ENDOLEAK, 28MM BELOW THE SUPERIOR MARGIN, WHICH MIGHT HAVE CONTRIBUTED TO THE REPORTED ENDOLEAK I-A. THERE MIGHT HAVE BEEN EVIDENCE OF A TYPE III-B ENDOLEAK AT THE BIFURCATION, INVOLVING THE LEFT LIMB EXTENSION. THE TYPE I-A ENDOLEAK WAS SUBSTANTIATED, AS WAS STENT COLLAPSE OF MAIN BODY AT A LUMBAR EMBOLIZATION AREA. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 56 MONTHS POST IMPLANT OF A BIFURCATED DEVICE, A SUPRARENAL, AND AN INFRARENAL AORTIC EXTENSIONS; A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REVEALED A PROXIMAL ENDOLEAK. THE PATIENT WAS TREATED WITH AN ADDITIONAL SUPRARENAL AORTIC EXTENSION, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. DURING THIS PROCEDURE, A COVERED STENT WAS ALSO IMPLANTED IN THE LEFT RENAL ARTERY. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300609 POWERLINK SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 34-34-100RLE W09-1668-011

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention