BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 3953476 · Received July 23, 2014

    Report

    Report Number
    2031527-2014-00225
    Event Type
    Death
    Date Received
    July 23, 2014
    Date of Event
    June 28, 2014
    Report Date
    July 6, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. COMPUTED TOMOGRAPHY IMAGING WAS PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE. THERE WAS NO EVIDENCE OF AN ON ANY OF THE CT SCANS PROVIDED FOR REVIEW. THE PRODUCT WAS USED OUTSIDE OF INDICATION OF THE IFU: THE SHORT AORTIC NECK (APPROXIMATELY 10MM), SEVERELY ANGLED AORTIC NECK (APPROXIMATELY 90°), JETTING CALCIFICATIONS AT THE BIFURCATION, MULTIPLE PATENT LUMBAR ARTERIES AND IMA. THE PATIENT'S ANTICOAGULATION THERAPY AND THE UNRESOLVED, UNTREATED ENDOTENSION MIGHT HAVE CONTRIBUTED TO THIS EVENT. THERE WAS EVIDENCE IN THIS CHALLENGING ANATOMY OF PROGRESSIVE STENT SEPARATION, STENT MIGRATION, AORTIC REMODELING, FABRIC DISRUPTIONS, AND PATENT ANCILLARY VESSELS. THE ENDOLEAK TYPE LEADING TO THE RUPTURE CANNOT BE DETERMINED BASED ON THE EVIDENCE. A MANUFACTURING RECORD REVIEW WAS PERFORMED; THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED THAT ALL UNITS WERE CONSUMED AND NO OTHER UNITS FROM THE SAME LOT HAVE BEEN INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING.

    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. EXPECTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 21 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, AN ENDOLEAK WAS IDENTIFIED IN REPEAT IMAGING. REPORTEDLY, THE PATIENT HAD BEEN SEEN ROUTINELY FOR FOLLOW UP AND A PROXIMAL ENDOLEAK HAD BEEN IDENTIFIED, BELIEVED TO POSSIBLY BE TYPE 1A. HOWEVER, IT APPEARED TO BE A PATENT IMA WHICH MAY HAVE PRODUCED A TYPE 2 ENDOLEAK. THE PATIENT PRESENTED TO THE HOSPITAL IN (B)(6) 2014 WITH SYMPTOMS SUGGESTING AN AORTIC ANEURYSM RUPTURE. A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED, WHICH CONFIRMED THE RUPTURE. AN OPEN REPAIR WAS PERFORMED AND THE DEVICES WERE EXPLANTED. REPORTEDLY, THE ANEURYSM CONTINUED TO EXPAND OVER THE 2 YEAR TIME PERIOD BETWEEN IMPLANT AND EXPLANT. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN STABLE CONDITION. THE REPORT RECEIVED INDICATES THE PATIENT PASSED AWAY IN THE HOSPITAL ON (B)(6) 2014. THE CAUSE OF THE PATIENT'S DEATH HAS NOT BEEN PROVIDED AT THE TIME OF THIS REPORT. THE IMPLANTING PHYSICIAN WAS NOT PRESENT AT THE HOSPITAL DURING THE EMERGENT PRESENTATION AND THE DEVICES WERE EXPLANTED BY ANOTHER PHYSICIAN, WHO COMMENTED: IT IS POSSIBLE THAT THE AORTIC EXTENSION HAD MOVED OVER TIME DUE TO TORTUOUS ANATOMY IN THE AORTIC NECK (THE NECK HAD A 90 DEGREES ANGULATION). THE AORTIC EXTENSION AND BIFURCATED DEVICE PRESENTED SOME DISLOCATION CAUSING AN ENDOLEAK BETWEEN THE COMPONENTS. UPON DEVICE EXPLANTATION, INSPECTION OF THE DEVICES REVEALED A PERFORATION IN THE SUPRARENAL EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430507 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA22-90/I16-30 1040862-025

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death