BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 4243582 · Received November 11, 2014

    Report

    Report Number
    2953200-2014-02379
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 5.8CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 16 MM IN DIAMETER AND 30 MM IN LENGTH. THE LEFT COMMON ILIAC ARTERY WAS 24-23 MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 9-11 MM IN DIAMETER. THE PROXIMAL NECK ANGULATION WAS MILD. THE PROXIMAL AND DISTAL AORTIC NECK HAD MODERATE CALCIFICATION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE CONTRALATERAL LIMB HAD DIFFICULTY PASSING THROUGH A CALCIFIC RING AT THE DISTAL NECK/BEGINNING OF ANEURYSM. WITH DIFFICULTY THE PHYSICIAN PUSHED THE CONTRALATERAL LIMB INTO THE CORRECT POSITION AND THE LIMB WAS DEPLOYED. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. A RELIANT BALLOON WAS THEN PASSED OVER-THE-WIRE AND THE GATE AREA AS WELL AS THE DISTAL LANDING ZONE OF THE CONTRALATERAL LIMB WAS DILATED. A RETROGRADE ANGIOGRAM WAS PERFORMED WHICH SHOWED A LARGE DISTAL TYPE I ENDOLEAK. THE DISTAL END OF THE 16X28MM FLARED GRAFT WAS NOT OPPOSED TO THE ARTERIAL WALL. A MORE AGGRESSIVE BALLOON DILATATION WAS PERFORMED AND THE RETROGRADE ANGIOGRAM REPEATED. THE DISTAL GRAFT HAD EXPANDED BUT WHAT APPEARED TO BE CONTRAST EXTRAVASATION WAS PRESENT. ANOTHER ENDURANT CONTRALATERAL LIMB WAS IMPLANTED WITHIN THE GATE AND EXTENDED INTO THE LEFT EXTERNAL ILIAC ARTERY WITHOUT COILING THE LEFT HYPOGASTRIC. THE DELIVERY SYSTEM WAS REMOVED WITHOUT DIFFICULTY AND LIGHT BALLOON DILATATION PERFORMED AT THE GATE AND AT THE DISTAL LANDING ZONE. A FINAL RETROGRADE INJECTION WAS PERFORMED WHICH SHOWED BOTH A PROXIMAL AND DISTAL SEAL BUT AN EXTREMELY FAINT BLUSH INTO THE PREVIOUS ANEURYSMAL LEFT COMMON ILIAC ARTERY. WITH THE PATIENT HEPARINIZED THE PHYSICIAN DECIDED TO CLOSELY FOLLOW THE PATIENT WITH CT TO SEE IF THIS DIMINISHES. THE PHYSICIAN STATED THAT THE EVENT WAS RELATED TO THE DEVICE AND THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726959 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V05890390

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention