BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 4240716 · Received November 10, 2014

    Report

    Report Number
    2031527-2014-00327
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    July 18, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. NO MEDICAL RECORDS OR IMAGING WERE PROVIDED FOR CLINICAL REVIEW; ONLY A SIZING SHEET WAS PROVIDED. PRODUCT APPROPRIATENESS AND PATIENT CANDIDACY COULD NOT BE FULLY ASSESSED. THE SIZING SHEET INDICATED AN ANATOMY THAT WAS CONGRUENT WITH THE IFU. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO RELATED ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED 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. BECAUSE THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND BECAUSE THERE WAS INADEQUATE CASE INFORMATION PROVIDED FOR REVIEW, A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, AN INFRARENAL AORTIC EXTENSION, AND A LIMB EXTENSION, A DISTAL OCCLUSION WAS NOTICED AND TREATED. REPORTEDLY, DURING INITIAL IMPLANT, THE LIMB EXTENSION HAD BEEN PLACED BETWEEN RCIA AND RIGHT EXTERNAL ILIAC ARTERY, AND IT WAS INDICATED THAT SOME UNSPECIFIED TIME AFTER THE PROCEDURE, AN OCCLUSION OF THE RCIA WAS OBSERVED. THE PHYSICIAN PERFORMED ON (B)(6) 2014 AN ADDITIONAL PROCEDURE TO TREAT THE OCCLUSION OF THE RCIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723470 POWERLINK SYSTEM LIMB EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 20-13-70FL 1129727-007

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention