BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 3827779 · Received May 22, 2014

    Report

    Report Number
    2031527-2014-00161
    Event Type
    Death
    Date Received
    May 22, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    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 A CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED EVENTS WERE CONFIRMED. THERE MIGHT HAVE BEEN PRODUCT USE THAT WAS INCONGRUENT WITH IFU DUE TO THE LACK OF AN ANEURYSMAL DISEASE, EXTENSIVE MURAL THROMBUS AND SEVERE RIGHT COMMON ILIAC STENOSIS. THE PATIENT HAD A HISTORY OF RENAL INSUFFICIENCY, WHICH MIGHT HAVE BEEN A CONTRIBUTING FACTOR. THE SHEATH INSERTION DIFFICULTY, THE MIGRATION OF STENT INTRA-OPERATIVELY, THE ACUTE RENAL FAILURE AND MALIGNANT ACIDOSIS THAT REQUIRED A DIALYSIS CATHETER INTRA-OPERATIVELY; AN OPEN CONVERSION AND DEATH WERE SUBSTANTIATED. 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 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, THE MOST LIKELY CAUSE FOR THE REPORTED EVENTS IS RELATED TO THE PATIENT'S VESSEL MORPHOLOGY AND PRODUCT HANDLING. THE PRODUCT USE APPEARS TO HAVE BEEN OFF-LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF A BIFURCATED DEVICE AND AN INFRARENAL AORTIC EXTENSION, THE EXTENSION WAS PLACED COVERING THE RENAL ARTERIES AND THE PROCEDURE WAS CONVERTED TO OPEN REPAIR. REPORTEDLY, THE BIFURCATED DEVICE WAS ADVANCED AND POSITIONED IN THE AORTA AND THE COVERED LIMBS OF THE BIFURCATED DEVICE WERE PLACED INTO THE RESPECTIVE ILIAC ARTERY. A COMPUTED TOMOGRAPHY RUN WAS PERFORMED, AND FOLLOWING VISUALIZATION, THE BIFURCATED DEVICE WAS DEPLOYED. THE AORTIC EXTENSION WAS CONSECUTIVELY IMPLANTED PROXIMAL TO THE BIFURCATED DEVICE. BALLOON DILATATION OF THE IMPLANTED DEVICES WAS PERFORMED [WITH A CODA BALLOON], AND IT APPEARS THAT THIS MIGHT HAVE RESULTED IN PUSHING THE DEVICES UP. REPEAT CT SHOWED THE AORTIC EXTENSION WAS COVERING THE RENAL ARTERIES FOR APPROXIMATELY 1 CM. THE PHYSICIAN ELECTED TO CONVERT TO OPEN REPAIR. DURING THE REPAIR IT WAS NOTED THAT THE RENAL ARTERIES WERE CLOTTED AND THE PATIENT'S POTASSIUM WENT UP. THE PHYSICIAN EXPLANTED THE DEVICES AND PERFORMED AN AORTO-FEMORAL BYPASS. THE PATIENT WAS TRANSFERRED TO THE ICU IN CRITICAL CONDITION. THE PATIENT PASSED AWAY LATER THAT NIGHT AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304883 AFX SYSTEM INFRARENAL PROXIMAL EXTENSION STENT MIH ENDOLOGIX, INC. A28-28/C75 V 1164389-008

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| O