BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 5065092 · Received September 9, 2015

    Report

    Report Number
    2031527-2015-00352
    Event Type
    Death
    Date Received
    September 9, 2015
    Date of Event
    January 22, 2015
    Report Date
    August 11, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE CLINICAL FINDINGS, THE REPORTED EVENT IS CONFIRMED. TWENTY EIGHT MONTHS POST IMPLANT, THERE WAS EVIDENCE TO SUPPORT: AN ACUTE THORACOABDOMINAL DISSECTION (TYPE B); A TYPE B INTRAMURAL HEMATOMA AT THE ARCH; HYPER DILATION OF BOTH THE CUFF (~ 42 MM) AND MAIN BODY SUPERIOR STENT MARGIN (31MM); COMPLETE COMPONENT SEPARATION; TYPE IIIA ENDOLEAK; TYPE IIIB ENDOLEAK OF THE CUFF AND MAIN BODY. THERE WAS INTERVAL SAC GROWTH OF APPROXIMATELY 1 CM, SINCE 2012. THE SECONDARY PROCEDURE OF A NEW THORACIC GRAFT (X2), AND PLACEMENT OF A SUPRARENAL BRIDGE STENT WAS CONFIRMED. ON THE FIRST POST-OPERATIVE DAY, THE PATIENT DEVELOPED ACUTE PUPIL DILATION. IMAGING STUDIES CONFIRMED DIFFUSE CEREBRAL INFARCTS (INVOLVING CEREBELLUM, PONS, MID BRAIN) WITH SUSPICION OF AN ACUTE THROMBUS OF THE LEFT VERTEBRAL ARTERY. THE PATIENT'S FAMILY WITHDREW CARE, AND THE PATIENT EXPIRED ON THE SECOND 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. BASED UPON THE INVESTIGATION FINDINGS, THE OVERALL INVESTIGATION IS INCONCLUSIVE. HOWEVER, PATIENT FACTORS THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT INCLUDED CONTINUED TOBACCO USE AND UNCONTROLLED HYPERTENSION WHICH MIGHT HAVE CONTRIBUTED AN ACCELERATED ANEURYSMAL DISEASE PROCESS AND THE CONFIRMED TYPE B AORTIC DISSECTION (AND TYPE B INTRAMURAL HEMATOMA)FROM THE LEFT SUBCLAVIAN TO JUST ABOVE THE RENAL ARTERIES.

    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. DEVICES ARE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PROCEDURE ON (B)(6) 2012 WITH A BIFURCATED AND A SUPRARENAL AORTIC EXTENSION. REPORTEDLY, PATIENT WAS IMPLANTED WITH A SUPRARENAL TO REDO ABDOMINAL AORTIC STENT GRAFT. PATIENT EXPIRED, AND IT IS NON RELATED TO OUR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596133 AFX SUPRARENAL AORTIC EXTENSION MIH ENDOLOGIX, INC. A34-34/C80-O20 1032597-019

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death