BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4171771 · Received October 15, 2014

    Report

    Report Number
    2031527-2014-00293
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    THE EXPLANTED DEVICE WAS RETURNED FOR EVALUATION. INSPECTION OF THE DEVICE SHOWED HEAVY MASS OF CLOT INSIDE THE BIFURCATED LIMB. A COMPETITOR STENT EXPLANTED FROM AN ILIAC ARTERY WAS HEAVILY OCCLUDED WITH CLOT MATERIAL AS WELL. TWO MASSES OF CLOTH MATERIAL WERE RETURNED SEPARATELY FROM THE DEVICES, AND CONTAINING COILS. IT IS UNKNOWN IF THESE MASSES WERE ORIGINALLY INSIDE THE RETURNED DEVICES WHILE IN THE PATIENT, OR NOT. ADDITIONALLY, MEDICAL RECORDS AND IMAGING STUDIES WERE RECEIVED AND REVIEWED BY AN INTERNAL CLINICAL SPECIALIST WITH THE FOLLOWING CONCLUSIONS: PRODUCT USE WAS INCONGRUENT WITH THE IFU AND MIGHT HAVE CONTRIBUTED TO THE DECISION TO EXPLANT ALL DEVICES FROM THE PATIENT DUE TO: THE GREATER THAN 60 DEGREE AORTIC NECK; THE BILATERAL ILIAC ARTERY ANEURYSMS OF GREATER THAN 2.3 CM IN DIAMETER; AND THE USE OF A LEFT HYPOGASTRIC SNORKEL. CAUTIONARY PRODUCT USE CONDITIONS THAT MIGHT HAVE ALSO CONTRIBUTED TO THE EVENT WERE: THE AORTIC EXTENSIONS WERE THE SAME DIAMETER SIZE AS THE BIFURCATED MAIN BODY; AND, MULTIPLE PATENT LUMBAR ARTERIES (ENDOLEAK TYPE II). OTHER CONTRIBUTING FACTORS INCLUDED: UNRESOLVED ENDO-TENSION; PROGRESSIVE STENT SEPARATION/REMODELING, AND/OR DISEASE PROGRESSION; THE TWO SEPARATE COIL PROCEDURES (AORTIC MID-BODY AND RIGHT ILIAC) MIGHT HAVE CHANGED THE INTEGRITY OF THE AORTIC STENTS. THERE WAS SUBSTANTIATED EVIDENCE OF: AN UNKNOWN ENDOLEAK, AORTIC RUPTURE, MURAL THROMBUS (DISTAL TO THE BIFURCATED MAIN BODY), AND SLIGHT INFERIOR MIGRATION OF THE AORTIC EXTENSION AT 34 MONTHS POST INDEX, WITH A THIRD, SUBSEQUENT PROCEDURE OF PROXIMAL AND ILIAC EXTENSIONS. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO RELATED ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED THAT ALL UNITS WERE CONSUMED AND NO OTHER UNITS WERE INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. BASED ON THE REVIEW OF THE AVAILABLE INFORMATION, THE CAUSE OF THE DEVICE EXPLANT APPEARS QUITE COMPLEX. DEVICE EVALUATION SUGGESTS THE DEVICES BECAME OBSTRUCTED. ALSO, THE CLINICAL REVIEW IDENTIFIED MURAL THROMBUS WITHIN THE STENT, A DISTAL ENDOLEAK OF UNKNOWN TYPE, A TYPE II ENDOLEAK (LUMBAR ARTERIES), RUPTURE OF THE ANEURYSM, ILIAC OBSTRUCTION AND AORTIC RUPTURE AS THE MOST LIKELY REASON FOR THE EXPLANT, ALTHOUGH, TREATMENT OF A NUMBER OF OFF-LABEL PATIENT CONDITIONS, IDENTIFIED IN THE CLINICAL ASSESSMENT, MAY BE THE UNDERLYING CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 34.6 MONTHS POST IMPLANT OF A BIFURCATED DEVICE, AN INFRARENAL AND A SUPRARENAL AORTIC EXTENSIONS, THE DEVICES WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653721 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-100/I16-40 W11-3992-026

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention