BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2970496 · Received February 20, 2013

    Report

    Report Number
    2953200-2013-00304
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 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 (ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (CONICALLY SHAPED AND AORTIC NECK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (CONICALLY SHAPED AORTIC NECK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR 65 MM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE AORTIC NECK WAS 17-22MM IN DIAMETER AND IT WAS 15MM LONG. IT WAS REPORTED THAT AFTER IMPLANTING THE BIFURCATED STENT GRAFT AND LIMBS A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. THE PHYSICIAN IMPLANTED AN AORTIC CUFF WHICH REDUCED THE ENDOLEAK BUT NOT FULLY RESOLVE IT. NO ADDITIONAL INTERVENTIONS WERE PERFORMED AND THE PHYSICIAN WILL MONITOR THE PATIENT. THE CAUSE OF THE ENDOLEAK IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74987 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00983858

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR