BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 3818720 · Received May 19, 2014

    Report

    Report Number
    2031527-2014-00132
    Event Type
    Death
    Date Received
    May 19, 2014
    Date of Event
    April 20, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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

    BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED DEATH IS CONFIRMED. THERE WERE SUBOPTIMAL MEDICAL RECORDS AND IMAGING STUDIES PROVIDED FOR THIS ASSESSMENT. THERE MIGHT HAVE BEEN CAUTIONARY PRODUCT PLACEMENT USE DUE TO THE RUPTURED STATE OF THE AORTA, AND A SHORT, CALCIFIED AORTIC NECK. BECAUSE THE RUPTURE OCCURRED PRIOR TO A STENT PLACEMENT, THIS COMPLAINT MIGHT BETTER BE DESCRIBED AS A DEATH ONLY. A COMPLICATION AND A 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 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. BASED UPON THE INVESTIGATION FINDINGS, THE ROOT CAUSE OF THE REPORTED EVENT IS DETERMINED TO BE RELATED TO PRE-OPERATIVE RUPTURE. THE DEVICE WAS NOT A CONTRIBUTING FACTOR AND WAS USED OFF-LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMERGENT IMPLANTATION OF A BIFURCATED DEVICE, THE PATIENT CODED AS PHYSICIAN WAS PLACING THE IMPLANT. REPORTEDLY, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) SYMPTOMATIC, WITH A RUPTURED ANEURYSM, AND THE PHYSICIAN ELECTED TO TREAT THE PATIENT USING AN ENDOVASCULAR APPROACH. THE PATIENT WAS UNSTABLE AND COULD NOT BE RESUSCITATED, AND ALLEGEDLY EXPIRED DUE TO RUPTURED ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295706 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT (BGI) MIH ENDOLOGIX, INC. BA28-90/I16-30 1047075-024

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| O