BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3002978 · Received March 13, 2013

    Report

    Report Number
    2953200-2013-00449
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). LACK OF INFORMATION (UNKNOWN CAUSE AND LOCATION OF ENDOLEAK). EVALUATION CONCLUSIONS: LACK OF INFORMATION (UNKNOWN CAUSE AND LOCATION OF ENDOLEAK). (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 7 CM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 28 MONTHS AGO. IT WAS REPORTED THAT THE PATIENT WAS LOST TO FOLLOW-UP AND PRESENTED EMERGENTLY TO THE ER WITH ABDOMINAL PAIN APPROXIMATELY FOUR WEEKS AGO. A CT WAS DONE AND SHOWED THAT THE ANEURYSM GREW TO 10 CM IN DIAMETER. THERE WERE NO VISIBLE ENDOLEAKS. THERE WAS A DISCOLORATION IN THROMBUS LAYERS AND SOME FRESH THROMBUS. THE DECISION WAS MADE TO CONVERT THE PATIENT TO OPEN REPAIR AND EXPLANT THE STENT GRAFT. THE PHYSICIAN STATED THAT THERE MUST HAVE BEEN AN ENDOLEAK AT ONE TIME. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105684 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00558008

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention