BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ILIAC EXTENSION GRAFT

    MDR report key: 6796562 · Received August 16, 2017

    Report

    Report Number
    2953200-2017-01284
    Event Type
    Injury
    Date Received
    August 16, 2017
    Date of Event
    March 7, 2017
    Report Date
    July 21, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OFF-LABEL, UNAPPROVED OR CONTRAINDICATED USE. NOT IMPLANTING A BIFURCATED SYSTEM. MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; ISOLATED SPONTANEOUS DISSECTION OF THE ILIAC ARTERIES: FALSE LUMEN EMBOLIZATION AS AN ADJUNCT TO PERCUTANEOUS STENT GRAFTING. BEATRICE FIORUCCI, NIKOLAOS TSILIMPARIS, FIONA ROHLFFS, SABINE WIPPER, EIKE SEBASTIAN DEBUS, AND TILO K¿OLBEL, HAMBURG, GERMANY AND PERUGIA, ITALY (ANN VASC SURG 2017; 42: 300.E1¿300.E5) HTTP://DX.DOI.ORG/10.1016/J.AVSG.2017.02.003 .

    Description of Event or Problem · 1

    AN 20X20X80 ENDURANT ILIAC EXTENSION WAS IMPLANTED IN PATIENT FOR ENDOVASCULAR TREATMENT OF A CHRONIC DISSECTION IN THE ILIAC ARTERY WITH A FALSE LUMEN ANEURYSM OF 44 MM DIAMETER. PRE-OPERATIVE CTSHOWED THAT THE LARGE PRIMARY ENTRY TEAR OF THE DISSECTION WAS AT THE LEVEL OF COMMON ILIAC ARTERY. THE DISSECTION EXTENDED DISTALLY TO THE EXTERNAL ILIAC ARTERY AND THE COMMON FEMORAL ARTERY AT THE BIFURCATION. THE HYPOGASTRIC ARTERY ORIGINATES FROM THE TRUE LUMEN. THE ILIAC ARTERY WAS TORTUOUS. THE PROXIMAL SEAL ZONE WAS SHORT. PRIOR TO THE INDEX PROCEDURE, THE STENT GRAFT WAS SURGEON-MODIFIED TO FIT THE PATIENT'S ANATOMY AND TO PRESERVE INTERNAL ILIAC ARTERIAL FLOW. IT WAS PARTIALLY DEPLOYED AND SHORTENED TO A LENGTH OF 65 MM USING ELECTROCAUTERIZATION. THE GRAFT WAS RESHEATHED INTO THE ORIGINAL DEPLOYMENT SYSTEM WITH THE HELP OF A RUBBER LOOP USED TO COLLAPSE EACH STENT. IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE MODIFIED STENT GRAFT, CONTROL ANGIOGRAPHY REVEALED POOR APPOSITION OF THE PROXIMAL EDGE OF THE STENT GRAFT; THEREFORE, THE ILIAC ALIMB WAS RELINED PROXIMALLY WITH A 12 X 41 MM COVERED STENT FROM ANOTHER MANUFACTURER, DILATED TO 16 MM RESULTING IN THE INTENDED POSITION OF THE STENT GRAFT IN THE TRUE LUMEN COVERING THE LARGE PROXIMAL ENTRY TAR. THE FALSE LUMEN WAS EMBOLIZED AT THE LEVEL OF THE PROXIMAL EXTERNAL ILIAC ARTERY WITH TWO 14-MM AND ONE 8-MM COILS TO OCCLUDE THE REMAINING CONNECTION TO THE LARGE FALSE LUMEN ANEURYSM. FINAL ANGIOGRAPHY SHOWED COMPLETE EXCLUSION OF THE FALSE LUMEN ANEURYSM. NO ENDOLEAK WAS OBSERVED DURING OR AFTER THE PROCEDURE. POST-OPERATIVE CTA PERFORMED 5 DAYS AFTER THE PROCEDURE CONFIRMED EXCLUSION OF THE FALSE LUMEN ANEURYSM, WITH COVERAGE OF THE ENTRY TEAR, AND NO FALSE LUMEN BACK FLOW. THE SMALL, SEGMENTAL DISSECTION PERSISTED AT THE DISTAL EXTERNAL ILIAC ARTERY AND COMMON FEMORAL ARTERY. POSTOPERATIVE COURSE WAS UNEVENTFUL AND THE PATIENT WAS DISCHARGED FROM HOSPITAL SEVEN DAYS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576828 ENDURANT ILIAC EXTENSION GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention