BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 4090335 · Received September 15, 2014

    Report

    Report Number
    2953200-2014-01832
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: PRE IMPLANT RUPTURE.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AFTER THE PROCEDURE (SAME DAY), THE PATIENT WAS COMPLAINING OF LEFT LEG PAIN. A CT SCAN WAS PERFORMED AND THE PATIENT¿S LEFT COMMON ILIAC WAS OCCLUDED AND THE RIGHT COMMON ILIAC SIZE WAS DIMINISHED AT PATIENT¿S ORIGINAL BIFURCATION. THE PHYSICIAN PERFORMED A THROMBECTOMY HOWEVER, WAS ONLY ABLE TO REMOVE CLOT FROM THE EXTERNAL ILIAC TO FEMORAL ARTERY AT ACCESS SITE. THE PHYSICIAN WAS UNABLE TO ACCESS THE LEFT COMMON ILIAC AND DURING THIS PROCESS CREATED A DISSECTED AREA IN THE LEFT DISTAL EXTERNAL ILIAC AND PLACED A VIABAHN STENT (7MM X 10CM) IN THE LEFT EXTERNAL ILIAC AND UPON PERFORMING A RETROGRADE ANGIOGRAM, THE LEFT HYPOGASTRIC ARTERY REMAINED OPEN. THE PHYSICIAN IMPLANTED AN ICAST STENT (10MM X 38MM) AT THE NARROW AREA ON THE RIGHT COMMON ILIAC AND THE AREA INCREASED FROM 7MM TO 10MM. RETROGRADE ANGIOGRAM WAS PERFORMED AND THE VESSEL WAS PERFUSING WELL. THE PHYSICIAN THEN PERFORMED A FEM-FEM BYPASS WITHOUT ISSUES. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568457 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04056110

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention