BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 2993777 · Received March 7, 2013

    Report

    Report Number
    2031527-2013-00034
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS NOT RETURNED, HENCE NO DEVICE EVALUATION WAS PERFORMED. STILL IMAGES WERE RECEIVED AND REVIEWED BY A CLINICAL REPRESENTATIVE. REVIEW OF THE IMAGES CONFIRMED OCCLUSION OF THE LEFT ILIAC ARTERY, WHICH WAS REPORTED AS THROMBOSED 10 DAYS PRIOR TO THE INDEX PROCEDURE. PRESENCE OF FLOW IN THE LEFT ILIAC ARTERY PREVIOUSLY THROMBOSED, WAS CONFIRMED IN THE IMAGES PROVIDED. THE LOT MET ALL RELEASE CRITERIA WITH NO RELEVANT NONCONFORMING MATERIAL RECORDS. THE LOT USAGE HISTORY SHOWS THAT NO OTHER UNITS FROM THIS LOT HAVE BEEN INVOLVED IN ANY SIMILAR COMPLAINTS AT THIS TIME. BASED ON THE REVIEW OF THE EVENT INFORMATION, STILL IMAGES PROVIDED AND MANUFACTURING RECORDS, A ROOT CAUSE FOR THE REPORTED THROMBOSIS IN THE STENT GRAFTS CANNOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE INSTRUCTIONS FOR USE LISTS: OCCLUSION OF DEVICE OR NATIVE VESSEL, UNDER POTENTIAL ADVERSE EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT OF A BIFURCATED STENT GRAFT, AND TWO LIMB EXTENSIONS (REFERENCE MDR # 2031527-2013-35 & 2031527-2013-36 ), THE STENT GRAFTS WERE ALLEGEDLY OCCLUDED. REPORTEDLY, WHILE IN THE RECOVERY ROOM THE PATIENT LOST PULSE IN THE LOWER EXTREMITIES. A COMPUTED TOMOGRAPHY SCAN REVEALED THROMBOSIS IN THE STENT GRAFTS BUT NO KINKS IN THE GRAFT WERE NOTED. THE STENT GRAFTS WERE BALLOONED AND THROMBOLYSIS WAS PERFORMED. AN ANGIOGRAM WAS PERFORMED TO CONFIRM THE PATENCY IN THE DEVICES. THE PHYSICIAN ADMINISTERED A TISSUE PLASMINOGEN ACTIVATOR (TPA) TO HELP MAINTAIN LUMEN POTENCY. THE FOLLOWING DAY THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER CARE DUE TO HEAD BLEED ASSOCIATED WITH AN UNRELATED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96868 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA22-90/I16-30 1047039-016

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention