BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ILIAC STENT GRAFT

    MDR report key: 2833891 · Received November 15, 2012

    Report

    Report Number
    2953200-2012-02197
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 25, 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). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION; ILIAC ARTERY DILATATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION; ILIAC ARTERY DILATATION).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 18-21 MM IN DIAMETER AND 14.5 MM IN LENGTH. DURING THE INDEX PROCEDURE A TYPE II ENDOLEAK WAS OBSERVED AND LEFT UNCORRECTED. IT WAS REPORTED THAT ONE WEEK POST INDEX PROCEDURE, THE CT SHOWED THAT THERE WAS EITHER A DISTAL TYPE I ENDOLEAK OR THE PREVIOUSLY REPORTED TYPE II ENDOLEAK. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. TWO MONTHS LATER, A ROUTINE FOLLOW UP CT REVEALED THAT THERE WAS A DISTAL TYPE I ENDOLEAK AND THE ANEURYSM HAS ENLARGED. THE PHYSICIAN COMMENTED THAT THE MIGRATION OR DILATATION OF THE LEFT DISTAL MIGHT BE THE CAUSE OF THE ENDOLEAK. THE PHYSICIAN ELECTED TO COIL THE INTERNAL ILIAC ARTERY AND EXTEND THE CONTRALATERAL ILIAC LIMB WITH AN ENDURANT EXTENSION LIMB. THE ENDOLEAK WAS RESOLVED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01086685

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention