BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2921052 · Received January 17, 2013

    Report

    Report Number
    2953200-2013-00107
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); LACK OF INFORMATION (CAUSE AND EXACT LOCATION OF ENDOLEAK IS UNKNOWN).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FILM REVIEW DETERMINED THAT THE TYPE IV ENDOLEAK WAS COMING FROM THE BIFURCATED STENT GRAFT. THE TYPE IV ENDOLEAK RESOLVED WITHOUT INTERVENTION. THE INTIAL MDR IS REDACTED.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. AN ENDURANT BIFURCATED STENT GRAFT (B)(4) AND THREE ILIAC STENT GRAFTS, (B)(4), WERE IMPLANTED. IT WAS REPORTED THAT ON THE FINAL ANGIOGRAM A TYPE IV ENDOLEAK WAS NOTED. THE EXACT LOCATION OF THE ENDOLEAK IS UNKNOWN. THE PATIENT WAS GIVEN 10,000 UNITS OF HEPARIN FOR THIS PROCEDURE. NO INTERVENTION WAS PERFORMED AND THE DECISION WAS MADE TO EVALUATE THE PATIENT FOR THE ENDOLEAK AT 30 DAY FOLLOW-UP APPOINTMENT. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26409 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00988189

    Patients

    Seq Age Sex Outcome Treatment
    1