BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3200270 · Received July 1, 2013

    Report

    Report Number
    2953200-2013-01227
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE ( ANEURYSM RUPTURE, ENDOLEAK, BLEEDING); (LACK OF INFORMATION, UNKNOWN CAUSE OF THE EVENT IS UNKNOWN). CONCLUSION: INHERENT RISK OF A PROCEDURE (ANEURYSM RUPTURE, ENDOLEAK, BLEEDING); (LACK OF INFORMATION, UNKNOWN CAUSE OF THE EVENT IS UNKNOWN).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT CAME IN EMERGENTLY WITH BELLY PAIN WHICH WAS NOTED TO BE A RUPTURED ANEURYSM. A CT SHOWED A RUPTURE/ENDOLEAK AND BLOOD WAS GIVEN TO THE PATIENT. THE ENDOLEAK WAS A TYPE III SEPARATION BETWEEN TWO OF THE LIMBS, UNKNOWN WHICH TWO LIMBS. THE CAUSE OF THE SEPARATION IS UNKNOWN. THE PATIENT WAS SUCCESSFULLY TREATED WITH AN ENDURANT 161693. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298409 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR 224414

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Required Intervention