BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 4552517 · Received February 26, 2015

    Report

    Report Number
    2031527-2015-00031
    Event Type
    Death
    Date Received
    February 26, 2015
    Date of Event
    January 28, 2015
    Report Date
    January 28, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: ADEQUATE MEDICAL DOCUMENTATION AND IMAGING STUDIES WERE AVAILABLE FOR THIS REVIEW. PRODUCT USE WAS INCONGRUENT WITH THE IFU DUE TO THE RUPTURED STATE OF THE ANEURYSM. CAUTIONARY PRODUCT USE CONDITIONS THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT INCLUDED THE NEAR 60 DEGREE ANGULATION OF THE AORTIC BLOOD LUMEN (AS OBSERVED ON THE IMPLANT ANGIOGRAM). DURING THE IMPLANT PROCEDURE, THERE WAS EVIDENCE TO SUPPORT AN INTRAOPERATIVE STENT MIGRATION. A PERSISTENT TYPE IB ENDOLEAK FROM THE LEFT COMMON ILIAC ARTERY WAS OBSERVED POST LIMB EXTENSION BUT WAS SUCCESSFULLY TREATED WITH A COMPETITOR'S STENT. ON THE FIRST POST-OPERATIVE DAY, THERE WAS A SUDDEN DECLINE IN THE PATIENT'S CONDITION. THERE WAS EVIDENCE TO SUPPORT A COMPLICATION OF ACUTE RENAL FAILURE, AND THE PRESUMED MASSIVE PULMONARY EMBOLI (FLAT SEPTUM/DILATED RIGHT VENTRICLE). PULSELESS ELECTRICAL ACTIVITY AND ASYSTOLE RESULTED IN DEATH ON THE FIRST POST-OPERATIVE DAY. 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 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, THE ROOT CAUSE IS DETERMINED TO BE DUE TO THE OFF-LABEL USE OF THE DEVICE IN AN EMERGENT CASE AND POST-OPERATIVE COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL EMERGENCY ROOM AND WAS SYMPTOMATIC WITH PAIN. THE HOSPITAL PERFORMED A COMPUTED TOMOGRAPHY SCAN WHICH INDICATED THE PATIENT HAD A RUPTURED AORTIC ANEURYSM. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A BIFURCATED DEVICE, TWO LIMB EXTENSION STENT GRAFTS, A SUPRARENAL AORTIC EXTENSION, AND AN INFRARENAL AORTIC EXTENSION. DURING THE PROCEDURE, THE PROXIMAL EXTENSION SLIPPED OUT OF THE NECK SO THE PHYSICIAN ADDED A SUPRARENAL AORTIC EXTENSION. AT THE CONCLUSION OF THE PROCEDURE AN ANGIOGRAM WAS PERFORMED AND IT WAS REPORTED THAT EVERYTHING LOOKED GOOD, THERE WAS NO ENDOLEAK, AND THE PATIENT'S BLOOD PRESSURE WAS STABLE. ON (B)(6) 2015 THE PHYSICIAN NOTIFIED THE SALES REP THAT THE PATIENT EXPIRED FROM A PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136575 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-110/I16-30 1264546-006

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death