BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2985735 · Received March 1, 2013

    Report

    Report Number
    2953200-2013-00376
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    June 14, 2014
    Report Date
    August 11, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: STENT GRAFT OCCLUSION, CLAUDICATION. LACK OF INFORMATION (UNKNOWN CAUSE OF OCCLUSION). CONCLUSION: UNKNOWN CAUSE OF OCCLUSION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 10.3 CM DIAMETER FUSIFORM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 28 MONTHS AGO. THE INFRA-RENAL NECK ANGLE WAS 60 DEGREES. THE AORTIC NECK WAS 24 MM IN DIAMETER AND 23 MM IN LENGTH. THE DISTAL AORTA WAS 37 MM IN DIAMETER. THE RIGHT ILIAC ARTERY WAS 17 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 18 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 10 MM IN DIAMETER. THE RIGHT AND LEFT ILIAC ARTERIES WERE MILDLY TORTUOUS WITH NO STENOSIS. THE 2813145 BIFURCATED STENT GRAFT AND ILIAC STENT GRAFT 1624C80EE WERE IMPLANTED ON THE RIGHT SIDE. A 1620120 AND A 202080 FROM THE LEFT SIDE. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH ACUTE LEFT LIMB ISCHEMIA 26 MONTHS POST IMPLANT. NO PULSATIONS WERE DETECTED IN THE LEFT LOWER EXTREMITY; THEREFORE, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A THROMBECTOMY AND THE EVENT RESOLVED. THE EVENT WAS REPORTED AS STENT GRAFT OCCLUSION. THE PHYSICIAN ASSESSED THE EVENT TO BE DEVICE RELATED AND NOT PROCEDURE RELATED. THE CAUSE OF THE THROMBUS IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    FILMS WERE RECEIVED AND REVIEWED. ANGIOGRAPHY IMAGES 2 YEARS POST-IMPLANT SHOWED THAT THE BIFURCATE IPSILATERAL LIMB AND EXTENSION WERE POSITIONED INTO THE RIGHT ILIAC, AND THE CONTRALATERAL LIMB AND EXTENSION INTO THE LEFT ILIAC. THE LEFT LIMB EXTENSION EXTENDS 1CM BEYOND THE CONTRA LIMB. NO CLEAR THROMBUS COULD BE SEEN WITHIN THE STENT GRAFT LIMBS OR AORTIC BODY. THE DISTAL STENT GRAFT OD IN THE REPORTED OCCLUDED LEFT LIMB MEASURED 23MM, AND THE DISTAL STENT GRAFT OD OF THE RIGHT ILIAC WAS 28MM. NO STENT GRAFT KINKS OR COMPRESSION WAS OBSERVED. IMAGES SHOWING THE OCCLUSION EVENT WERE NOT PROVIDED, AND THE CAUSE IS UNKNOWN. THE EVENT MAY BE PATIENT RELATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. IT WAS REPORTED THAT THE CT REVEALED THAT THE ABDOMINAL AORTIC ANEURYSM IS 8.2 CM IN DIAMETER, THE RIGHT LIMB IS 33 MM IN DIAMETER. THERE WERE DISTAL BILATERAL TYPE I ENDOLEAKS PRESENT. THE PHYSICIAN IMPLANTED AORTIC EXTENSIONS BILATERALLY. THE FOLLOW UP CT REVEALED THAT THE BILATERAL DISTAL TYPE I ENDOLEAKS WERE RESOLVED. THE INVESTIGATOR INDICATED THIS WAS RELATED TO THE DEVICE BUT NOT RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90403 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00520014

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention