BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2914503 · Received January 14, 2013

    Report

    Report Number
    2953200-2013-00085
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    November 9, 2012
    Report Date
    December 16, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (DISSECTION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASED, PRE-OPERATIVE PARTIALLY DISSECTED ILIAC ARTERIES). UNAPPROVED USE OF DEVICE (TREATMENT OF A PATIENT WITH AORTIC NECK DIAMETER LESS THAN 19 MM). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASED, PRE-OPERATIVE PARTIALLY DISSECTED ILIAC ARTERIES). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (TREATMENT OF A PATIENT WITH AORTIC NECK DIAMETER LESS THAN 19 MM).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 3.9 CM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY TWO MONTHS AGO. THE PROXIMAL NECK WAS 17 MM IN DIAMETER AND 53 MM IN LENGTH. THE AORTIC NECK ANGLE WAS 40 DEGREE. THE RIGHT EXTERNAL ILIAC ARTERY MEASURED 7.3 MM IN DIAMETER AND THE LEFT EXTERNAL ILIAC ARTERY MEASURED 6.5 MM IN DIAMETER. THE ILIAC ARTERIES HAD PARTIAL DISSECTIONS AND WERE DISEASED. AN ENDURANT BIFURCATED STENT GRAFT ENBF2313C166EJ AND A CONTRALATERAL LIMB ENLW1613C93EJ WERE SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT ONE DAY POST IMPLANT THE PATIENT PRESENTED WITH A DISSECTION COMING FROM LEFT COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. THE PATIENT WAS TREATED WITH AN ENDURANT STENT GRAFT APPROXIMATELY THREE WEEKS AGO. A CT SCAN WAS PERFORMED AND SHOWED THE ENTRY OF DISSECTION WAS SUCCESSFULLY COVERED WITH THE ENDURANT STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19904 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01142691

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention