BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3073316 · Received April 23, 2013

    Report

    Report Number
    2953200-2013-00757
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 29, 2013
    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). RESULTS: INHERENT RISK OF PROCEDURE (INACCURATE STENT GRAFT DELIVERY); (UNKNOWN CAUSE OF EVENT). CONCLUSION: UNKNOWN CAUSE OF EVENT).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 90MM IN DIAMETER AND 114MM IN LENGTH F USIFORM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK WAS 19.6MM IN DIAMETER AND 18MM IN LENGTH. THE RIGHT COMMON ILIAC ARTERY WAS 14 MM IN DIAMETER AND 26 MM IN LENGTH; THE LEFT COMMON ILIAC ARTERY WAS 14.5 MM IN DIAMETER AND 28 MM IN LENGTH. THE RIGHT INTERNAL ILIAC ARTERY WAS 17 MM IN DIAMETER; THE LEFT WAS 16.5 MM IN DIAMETER. THE RIGHT EXTERNAL ILIAC ARTERY WAS 8.6 MM IN DIAMETER; THE LEFT EXTERNAL ILIAC ARTERY WAS 8.6 MM IN DIAMETER. IT WAS REPORTED THAT AFTER DEPLOYMENT OF MAIN BODY AND CONTRA LIMB, AN ILIAC EXTENSION WAS ADDED TO THE DISTAL SIDE. LANDING WAS DONE WITH ANGIOGRAPHY JUST ABOVE THE LEFT INTERNAL ILIAC ARTERY AND EXTERNAL ILIAC ARTERY. HOWEVER, THE STENT GRAFT UNINTENTIONALLY COVERED THE LEFT INTERNAL ILIAC ARTERY AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS IS STABLE. NO CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT GRAFT MOVED WHILE THE PHYSICIAN WAS DEPLOYING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174605 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03024734

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR