BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ILIAC STENT GRAFT

    MDR report key: 4933195 · Received July 22, 2015

    Report

    Report Number
    2953200-2015-01109
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    June 29, 2015
    Report Date
    June 30, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 88MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 23-22-20MM IN DIAMETER AND 10 MM IN LENGTH. THE LEFT COMMON ILIAC ARTERY WAS 11-12-11MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 11-10-13MM IN DIAMETER. IT WAS REPORTED THAT THE PATIENT FELT WEAKNESS AND PAIN. THE PHYSICIAN CONTRIBUTED THE PATIENT SYMPTOMS TO CLAUDICATION OF THE LEFT 16X13X124 ENDURANT II LIMB. THE CAUSE OF THE EVENT IS UNKNOWN PER PHYSICIAN. THE PHYSICIAN ELECTED TO PERFORM AN ENDARTERECTOMY PROCEDURE. THE PHYSICIAN INSERTED A BALLOON EXPANDABLE STENT IN THE AREA OF THE ENDURANT II CONTRALATERAL GATE OVERLAP WHICH SUCCESSFULLY RESOLVED THE EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF PRE-IMPLANT CTA¿S REVEALED THAT THE PATIENT HAD A 5CM MAX DIAMETER AAA. THE PROXIMAL NECK FLOW LUMEN MEASURED 20MM IN DIAMETER AND APPROXIMATELY 3CM IN LENGTH. THE INFRARENAL NECK WAS ANGULATED 60DEG MAX L-R, AND FREE OF CALCIFICATION. THE DISTANCE FROM THE RENALS TO THE DISTAL AORTA WAS 7 ¿ 8 CM¿S. THE DISTAL AORTIC DIAMETER WAS 18MM, 2.5CM LONG, WITH AREAS OF CALCIFICATION. THE RIGHT COMMON ILIAC ARTERY DIAMETER WAS 11MM, AND THE LEFT COMMON ILIAC ARTERY MEASURED 12MM. THE ILIACS WERE NON-TORTUOUS. REVIEW OF CTA¿S FROM 4 WEEKS POST-IMPLANT REVEALED THAT THE BIFURCATE WAS POSITIONED JUST BELOW THE LOWEST LEFT RENAL ARTERY. THE IPSI LIMB WAS POSITIONED DOWN INTO THE RIGHT COMMON ILIAC ARTERY AND THE CONTRA LIMB INTO THE LEFT COMMON ILIAC. THE BOTTOM OF THE BIFURCATE GATE WAS PLACED WITHIN THE DISTAL AORTA. BEGINNING JUST BELOW THE FLOW DIVIDER, THE CONTRA/LEFT LIMB WAS TOTALLY OCCLUDED. THE BLOOD FLOW RESUMED DISTAL TO THE STENT GRAFT BEGINNING AT THE LEFT INTERNAL ILIAC AND LEFT FEMORAL ARTERY. THE RIGHT LIMB WAS PATENT. THE STENT GRAFT AORTIC BODY OD WITHIN THE NECK WAS 20MM, AND MEASURED 17X21MM ACROSS BOTH LIMBS WITHIN THE DISTAL AAA SAC, AND AT THE LEVEL OF THE GATE RING WAS 19 X 20MM. THE MINIMUM CONTRA LIMB ID WAS 7MM WITHIN THE DISTAL AORTA (AT THE GATE RING). THE MAX DIAMETER AAA MEASURED 5CM AND NO ENDOLEAK WAS OBSERVED. THE OCCLUDED LEFT/CONTRA LIMB STENT GRAFT OD RANGED FROM 15 ¿ 13MM WITHIN THE LEFT ILIAC, AND THE PATENT RIGHT/IPSI LIMB STENT GRAFT OD RANGED FROM 13-14MM. THE EXACT CAUSE OF THE OCCLUSION COULD NOT BE DETERMINED. IT IS POSSIBLE THAT IMPLANTING THE BIFURCATE WITHIN THE NARROWED AND CALCIFIED DISTAL AORTA MAY HAVE CONSTRICTED THE BLOOD FLOW TO THE POINT WHERE THE BLOOD FLOW EVENTUALLY THROMBOSED AND OCCLUDED. THIS MAY ALSO BE A PATIENT CONDITION. IMAGES POST-INTERVENTION WERE NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475869 ENDURANT II ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V06099413

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention