BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3903435 · Received June 30, 2014

    Report

    Report Number
    2953200-2014-01320
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NECK ANGULATION GREATER THAN 60 DEGREE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT¿S PROXIMAL NECK WAS 23-26 MM IN DIAMETER AND 13 MM IN LENGTH. THE LEFT COMMON ILIAC ARTERY WAS 11-12-10 MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 10-14-10 MM IN DIAMETER. THE RIGHT EXTERNAL ILIAC ARTERY MEASURED 7-7.5 MM IN DIAMETER AND THE LEFT EXTERNAL ILIAC ARTERY MEASURED 7.5 MM IN DIAMETER. THE NECK ANGLE WAS 70 DEGREE.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 6.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE ENDURANT BIFURCATE WAS DELIVERED IN A TORTUROUS NECK AND THE DEVICE WAS IMPLANTED ABOUT 1 CM LOWER THAN INTENDED. THE RESULT AFTER FINISHING THE REST OF THE IMPLANT WAS A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ATTEMPTED TO RESOLVE THE ENDOLEAK WITH AN ENDURANT AORTIC CUFF AND UNINTENTIONALLY PARTIALLY COVERED THE LEFT RENAL ARTERY. THE CUFF DID NOT RESOLVE THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379439 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04236675

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention