BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 2457773 · Received February 16, 2012

    Report

    Report Number
    2031527-2012-00007
    Event Type
    Death
    Date Received
    February 16, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 17, 2012
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. THE DEVICE WAS NOT RETURNED; THEREFORE, THE ACTUAL DEVICE WILL NOT BE EVALUATED. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    PATIENT'S CONDITION AFFECTED THE EFFECTIVENESS OF THE DEVICE. USE OF DEVICE TO TREAT A RUPTURED ANEURYSM IS CONSIDERED OFF-LABEL PER INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2012, A PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM (OFF LABEL USE). THE PHYSICIAN SUCCESSFULLY IMPLANTED A BIFURCATED DEVICE AND A 34 MM AORTIC EXTENSION. THE PROCEDURE WAS COMPLETED WITHOUT ANY SIGNS OF ENDOLEAKS PRESENT. THE NEXT MORNING, THE PATIENT COMPLAINED OF ABDOMINAL PAIN, A COMPUTED TOMOGRAPHY SCAN REVEALED PROXIMAL TYPE I ENDOLEAK. THAT SAME DAY, THE PHYSICIAN TREATED THE PATIENT WITH A BALLOON EXPANDABLE AORTIC STENT WHICH CORRECTED THE ENDOLEAK. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT, WHERE AFTER FOUR DAYS, THE PATIENT'S COGNITIVE ABILITIES DID NOT FULLY RETURN. AN IMAGING STUDY WAS PERFORMED ON THE PATIENT, WHICH REVEALED THE PATIENT HAD SUFFERED SEVERAL STROKES. THE PATIENT'S FAMILY ELECTED TO DISCONTINUE USE OF LIFE SUPPORTING DEVICES; IT WAS REPORTED THE PATIENT DIED ON (B)(6) 2012. THE PHYSICIAN BELIEVES THE CAUSE OF THE STROKES WAS THE PATIENT'S HYPOTENSION FOLLOWING THE ABDOMINAL AORTIC ANEURYSM RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C100-O20 W11-5715-012

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death