BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2920661 · Received January 17, 2013

    Report

    Report Number
    2953200-2013-00097
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 22, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION). LACK OF INFORMATION (UNKNOWN CAUSE OF OCCLUSION). .CONCLUSION: LACK OF INFORMATION (UNKNOWN CAUSE OF OCCLUSION).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD SECONDARY INTERVENTION WHERE AN ENDURANT CUFF AND TWO ANEURX ILIAC LIMBS WERE IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    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 APPROXIMATELY TWO MONTHS AGO. AN ENDURANT BIFURCATED STENT GRAFT ETBF2816C166E WAS IMPLANTED FROM THE RIGHT SIDE AND AN ENDURANT CONTRALATERAL LIMB ETLW1616C124E FROM THE LEFT. NO COMPLICATIONS WERE REPORTED SINCE IMPLANT. APPROXIMATELY ONE MONTH POST IMPLANT THE PATIENT PRESENT EMERGENTLY COMPLAINING OF LEG HEAVINESS/NUMBNESS. A CT SCAN WAS DONE AND IT WAS DISCOVERED THAT THE ETLW1616C124E CONTRALATERAL LIMB HAS COMPLETELY OCCLUDED THE LEFT COMMON ILIAC ARTERY WITH RECONSTITUTION OF THE LEFT INTERNAL/EXTERNAL ILIAC ARTERIES. THERE WAS NO EVIDENCE OF KINKING OR TWISTING. THE CAUSE OF THE OCCLUSION IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26604 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01708006

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention