BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 2660272 · Received July 18, 2012

    Report

    Report Number
    2031527-2012-00098
    Event Type
    Death
    Date Received
    July 18, 2012
    Date of Event
    June 12, 2012
    Report Date
    June 19, 2012
    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

    THE DEVICE WAS NOT RETURNED; THEREFORE, THE ACTUAL DEVICE WILL NOT BE EVALUATED. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NECK LENGTH MEASUREMENT 10-12MM WHICH IS AN "OFF-LABEL" CASE. PER INSTRUCTION FOR USE, IT INDICATED THAT "NON-ANEURYSMAL AORTIC NECK BETWEEN THE RENAL ARTERIES AND THE ANEURYSM WITH A LENGTH OF EQUAL OR GREATER THAN 15 MM." PATIENT'S CONDITION AFFECTED THE EFFECTIVENESS OF THE DEVICE. PATIENT'S CONDITION CONTRAINDICATED USE OF DEVICE. 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.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH NECK LENGTH MEASUREMENT 10-12MM WHICH IS AN "OFF LABEL" CASE. PATIENT RECEIVED AN IMPLANT OF A 28MM BIFURCATED DEVICE (REFERENCE TO MDR NUMBER: 2031527-2012-00098) AND A 34MM AORTIC EXTENSION ON (B)(6) 2012. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE WELL. PATIENT DISCHARGED ON (B)(6) 2012. THE PATIENT RETURNED ON (B)(6) 2012 WITH SEVERE ABDOMINAL PAIN, HYPOTENSION, LIGHTHEADNESS, AND DIAGNOSED WITH ACUTE RENAL FAILURE AND CONTAINED RUPTURE. PER THE PHYSICIAN, IT MAY HAVE BEEN FROM POST DILATING THE PROXIMAL NECK, ALTHOUGH THE PATIENT HAD SEVERAL PRE-EXISTING MEDICAL CONDITIONS. ALL DEVICES WERE EXPLANTED. EXPLANT DEVICES WERE DISCARDED ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT TOLERATED THE OPEN REPAIR WELL BUT EXPIRED POST OPERATIVELY. THE DATE OF DEATH AND CAUSE OF DEATH ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-90/I16-30 W11-6369-016

    Patients

    Seq Age Sex Outcome Treatment
    1 90 Death