BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 3181087 · Received June 20, 2013

    Report

    Report Number
    2031527-2013-00146
    Event Type
    Death
    Date Received
    June 20, 2013
    Date of Event
    May 25, 2013
    Report Date
    May 25, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. REMAINS IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS NOT RETURNED HENCE NO DEVICE EVALUATION WAS PERFORMED. HOWEVER, DEATH CERTIFICATE WAS AVAILABLE FOR REVIEW AND INDICATED THAT CAUSE OF PATIENT'S DEATH IS DUE TO RUPTURED ANEURYSM. TREATING PATIENTS WITH RUPTURED ANEURYSM IS CONSIDERED "OFF-LABEL" USE OF THE DEVICE. REVIEW OF LOT RECORDS, WORK ORDERS AND PRIOR REPORTS NO ISSUES WERE NOTED. BASED UPON THE INVESTIGATION FINDINGS, NO ISSUE WAS IDENTIFIED WITH ENDOLOGIX PRODUCT. RATHER, THE PATIENT DEATH WAS ATTRIBUTED TO THE PRE-EXISTING ANEURYSM RUPTURE WHICH WAS EMERGENTLY USED (OFF-LABEL) IN AN ATTEMPT TO TREAT RUPTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION TO EMERGENTLY TREAT AN ANEURYSM RUPTURE THE PATIENT EXPIRED DUE TO IRREGULAR HEARTBEAT. REPORTEDLY, THE PATIENT PRESENTED WITH RUPTURED ANEURYSM AND CODED INTRA-OPERATIVELY. RESUSCITATION EFFORTS WERE MADE AND THE PATIENT REGAINED PULSE AND BLOOD PRESSURE STABILIZED. AFTER SUCCESSFUL IMPLANTATION OF THE BIFURCATED DEVICE AND SUPRARENAL AORTIC EXTENSION THE PATIENT¿S BLOOD PRESSURE DROPPED DUE TO IRREGULAR HEARTBEAT AND ONCE AGAIN CODED. THE PHYSICIAN PERFORMED AN ABDOMINAL CUT DOWN AND CONFIRMED THE GRAFT WAS STILL IN GOOD POSITION AND SEALED. THE PRESENCE OF POOLED BLOOD WAS NOTED WHICH THE PHYSICIAN BELIEVES WAS DUE TO THE RUPTURE PRIOR TO THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO RE-STABILIZE THE PATIENT BUT PATIENT NEVER REGAINED NORMAL HEART RHYTHM AND EXPIRED IN INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280947 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-110/I20-30 1101020-020

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death