BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2962303 · Received February 14, 2013

    Report

    Report Number
    2953200-2013-00248
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    November 13, 2012
    Report Date
    November 22, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, METHOD: (FILM). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANGULATED ILIAC ARTERIES, ANEURYSM MORPHOLOGY CHANGES); INCORRECT TECHNIQUE/PROCEDURE (INSUFFICIENT STENT GRAFT OVERLAP). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANGULATED ILIAC ARTERIES, ANEURYSM MORPHOLOGY CHANGES); OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (INSUFFICIENT STENT GRAFT OVERLAP).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 41 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. A CT DONE APPROXIMATELY TWO MONTHS AGO NOTED THAT THE ILIAC EXTENSION HAS MIGRATED WITH A POSSIBLE TYPE III ENDOLEAK SEPARATION BETWEEN THE BIFURCATED STENT GRAFT AND THE IPSILATERAL EXTENSION. THE CONTRALATERAL LIMB HAS SEPARATED FROM THE GATE; HOWEVER, AN ENDOLEAK COULD NOT BE CONFIRMED. THE PATIENT WAS TREATED WITH AN ENDURANT ILIAC EXTENSION STENT GRAFT (B)(4) TO SUCCESSFULLY BRIDGE BETWEEN THE MIGRATED COMPONENTS. THE PROCEDURE WENT WELL. IT WAS REPORTED THAT THE CAUSE OF THE EVENT IS DUE TO INSUFFICIENT OVERLAP BETWEEN THE COMPONENTS COMBINED WITH THE STENT GRAFT LIMBS CROSSING OVER EACH OTHER. IN THIS CASE IT SEEMS THAT THE SECOND LIMB IS LIKE A SPIRAL AROUND THE IPSILATERAL LIMB. NO ADDITIONAL INFORMATION AND PROVIDED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF FILMS AT IMPLANT SHOW THAT THE IPSILATERAL LIMB AND EXTENSION WERE PLACED INTO THE RIGHT ILIAC. THERE APPEARED TO BE INSUFFICIENT OVERLAP BETWEEN THE IPSILATERAL AND EXTENSION (APPROXIMATELY 1.5CM). THE CONTRALATERAL AND CONTRALATERAL EXTENSIONS WERE PLACED IN THE LEFT ILIAC. THERE WAS GOOD OVERLAP AT THE GATE, BUT THE CONTRALATERAL EXTENSION WAS ONLY OVERLAPPING THE CONTRALATERAL LIMB BY APPROXIMATELY 1.5CM. FOLLOW-UP IMAGES DID NOT SHOW ANY OBVIOUS STENT GRAFT ISSUES. FOLLOW-UP CTA SHOW THAT SIGNIFICANT ANEURYSM MORPHOLOGY AND STENT GRAFT APPEARANCE CHANGES. THE IPSILATERAL EXTENSION HAS SEPARATED FROM THE IPSILATERAL LIMB, WITH A TYPE III JUNCTIONAL ENDOLEAK. THE ORIGIN OF THE CONTRALATERAL LIMB IS HIGHLY ANGULATED; ALTHOUGH NO ENDOLEAK IS SEEN AT THE CONTRALATERAL GATE OR ALONG THE CONTRALATERAL LIMBS. IT IS UNCLEAR IF THE LIMBS HAD MIGRATED. THE CAUSE OF THE TYPE III ENDOLEAK APPEARS TO BE INSUFFICIENT OVERLAP AT IMPLANT, IN COMBINATION WITH ANEURYSM MORPHOLOGY CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65920 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00340667

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention