BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 6192531 · Received December 21, 2016

    Report

    Report Number
    2031527-2016-00588
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 21, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    UDI-DI
    00818009013637
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICES HAVE NOT BEEN RETURNED.

    Additional Manufacturer Narrative · 1

    AT THE COMPLETION OF THE COMPLAINT INVESTIGATION, BASED ON THE INFORMATION RECEIVED, THE CLINICAL EVALUATION WAS ABLE TO CONFIRM THE SUBOPTIMAL PLACEMENT OF THE SUPRARENAL PROXIMAL EXTENSION ABOVE THE SUPERIOR MESENTERIC ARTERY (SMA). DUE TO INSUFFICIENT MEDICAL INFORMATION AND IMAGING THE NECROTIC SMALL INTESTINE COULD NOT BE CONFIRMED. THE CLINICAL EVALUATION ADDITIONALLY FOUND EVIDENCE TO REASONABLY SUGGEST THE FOLLOWING CONTRIBUTING FACTORS TO THE REPORTED EVENT; OFF LABEL USE, SUPERIOR MESENTERIC ARTERY WAS SITUATED 5 MM BELOW THE RIGHT RENAL ARTERY, AND MINIMAL CONTRAST USAGE DURING IMPLANT ANGIOGRAM DUE TO RENAL INSUFFICIENCY AND ONE FUNCTIONAL KIDNEY. THE MANUFACTURING EVALUATION DID NOT REVEAL ANY ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE EVENT DEVICES WERE NOT RETURNED FOR FURTHER EVALUATION. THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN. THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. CORRECTION: PATIENT CODES AND DEVICE CODES UPDATED BASED ON THE EVALUATION OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    PATIENT INITIALLY IMPLANTED ON (B)(6) 2016 WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION. ON (B)(6) 2016 THE PATIENT CAME IN EMERGENTLY WITH ABDOMINAL PAIN AND COMPUTED TOMOGRAPHY (CT) SHOWED THE SUPERIOR MESENTERIC ARTERY (SMA) WAS COVERED BY THE PROXIMAL EXTENSION. THE CT ALSO SHOWED BOWEL ISCHEMIA. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR ACUTE ABDOMEN AND HAD A NECROTIC SMALL INTESTINE. THE DIAGNOSIS WAS TERMINAL AND THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT FOR COMFORT CARE. THE PATIENT EXPIRED ON (B)(6) 2016 DUE TO BOWEL NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843816 AFX AORTO UNI-ILIAC [SUPRARENAL] MIH ENDOLOGIX INC. A28-28/C95-O20 V 1593636-011 00818009013637

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death BIFURCATED STENT- (B)(4)