BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 2949374 · Received February 7, 2013

    Report

    Report Number
    2031527-2013-00030
    Event Type
    Death
    Date Received
    February 7, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. (B)(4) : DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE DELIVERY SYSTEMS AND/OR STENT GRAFTS WERE NOT RETURNED FOR EVALUATION. HOWEVER, OPERATIVE NOTES FROM THE INDEX PROCEDURE AND EXPLORATORY LAPAROTOMY WERE REVIEWED BY CLINICAL REPRESENTATIVE. THE DEVICE INSTRUCTIONS FOR USE INDICATE: CARE SHOULD BE TAKEN IN AREAS OF STENOSIS, INTRAVASCULAR THROMBOSIS OR IN CALCIFIED AND/OR TORTUOUS VESSELS. BASED ON REVIEW OF AVAILABLE RECORDS, THE PATIENT HAD SEVERE BILATERAL ILIAC ARTERY STENOTIC DISEASE WHICH WAS LIKELY THE CAUSE OF THIS EVENT.. PER THE DEVICE HISTORY RECORD REVIEW, THE DEVICE WAS MANUFACTURED ACCORDING TO ENDOLOGIX SPECIFICATIONS. BASED ON THE REVIEW OF THE EVENT, INFORMATION AVAILABLE, MANUFACTURING RECORDS, AND PREVIOUS COMPLAINTS, THERE IS NO EVIDENCE THAT THIS COMPLAINT IS DUE TO A MANUFACTURING ISSUE AND THERE IS NO INDICATION THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE DAY POST-IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION (REFER TO MDR REPORT # 2031527-2013-00016), THE PATIENT EXPIRED. REPORTEDLY, THE PATIENT TOLERATED THE IMPLANT PROCEDURE WELL AND WAS IN RECOVERY. HOWEVER, THE PHYSICIAN WAS CALLED IN THE NEXT DAY DUE TO A DROP IN PATIENT'S BLOOD PRESSURE. THE PHYSICIAN ELECTED TO PERFORM AN ABDOMINAL INCISION, BUT WAS UNABLE TO GAIN CONTROL OF BLEEDING AND PATIENT CODED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52513 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-80/I16-40 1046814-002

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death