BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3900358 · Received June 27, 2014

    Report

    Report Number
    2953200-2014-01301
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 58MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK WAS 22MM IN DIAMETER AND 35MM IN LENGTH. THE DEGREE OF ANGULATION WAS 5. THERE WAS MILD VESSEL TORTUOSITY AND NO VESSEL CALCIFICATION. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CLAUDICATION AND PAIN. THE SMALL AORTIC BIFURCATION CAUSED THE ENDURANT IPSILATERAL LIMB ON THE RIGHT SIDE TO COMPRESS CAUSING LIMB OCCLUSION. THE CONTRALATERAL LIMB WAS PATENT AND WORKING WELL. THE PHYSICIAN INTERVENED AND USED A FOGARTY THROMBOLYSIS CATHETER AND STENTED THE LIMB WITH A BARE METAL BALLOON EXPANDABLE STENT RESOLVING THE EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF RETURNED CTA'S PRE-IMPLANT REVEALED THAT THE PROXIMAL NECK DIAMETER WAS 21MM BELOW THE RENALS; THE NECK WAS LONG AND CALCIFIED. THE AAA MAX DIAMETER WAS 5.5CM, AND CONTAINED THROMBUS (3.5CM FLOW LUMEN). THE DISTAL AORTA DIAMETER WAS APPROXIMATELY 20MM X 10MM AND WAS SEVERELY CALCIFIED. THE ILIACS WERE MILDLY TORTUOUS, BUT CALCIFIED. ANGIO IMAGES DURING IMPLANT SHOW THAT THE BIFURCATE WAS IMPLANTED FROM THE RIGHT SIDE, AND DEPLOYED JUST BELOW THE RENALS. THE IPSI LIMB WAS PLACED INTO THE RIGHT COMMON ILIAC AND THE CONTRA LIMB INTO THE LEFT COMMON ILIAC. THE DISTAL AORTIC DIAMETER ACROSS BOTH LIMBS WAS APPROXIMATELY 15MM (L-R). NO KINKS OR OCCLUSION WAS SEEN WITHIN EITHER LIMB, AND UNABLE TO CONFIRM ANY STENT GRAFT COMPRESSION. NO ENDOLEAK IS SEEN. IMAGES DURING AN ANGIO STUDY 2 WEEKS POST-IMPLANT REVEALED THAT THE DISTAL 4 STENT LENGTH OF THE IPSI/RIGHT LIMB IS OCCLUDED. UNABLE TO CONFIRM IF THE PROXIMAL PORTION OF THE IPSI LIMB MAY HAVE ALSO BEEN OCCLUDED. THE OD OF THE IPSI LIMB IN THE PROXIMAL (OCCLUDED) SECTION OF THE RIGHT ILIAC IS APPROXIMATELY 9MM. NO OBVIOUS KINKS OR COMPRESSION CAN BE SEEN IN THE IMAGES; THE OD ACROSS BOTH LIMBS NEAR THE DISTAL AORTA IS APPROXIMATELY 13MM. POST-INTERVENTION WITH STENTS IMPLANTED INTO THE IPSI LIMB RESOLVED THE OCCLUSION. THE EXACT CAUSE OF THE OCCLUSION IS UNKNOWN; HOWEVER, IT IS LIKELY THAT THE NARROW AND CALCIFIED DISTAL AORTA CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376767 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04238148

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention