BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3083504 · Received April 29, 2013

    Report

    Report Number
    2953200-2013-00808
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 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 (OCCLUSION); LACK OF INFORMATION (CAUSE OF OCCLUSION IS UNKNOWN). CONCLUSION: LACK OF INFORMATION (CAUSE OF OCCLUSION IS UNKNOWN).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM AAA AND AN ILIAC ANEURYSM. THE LEFT INTERNAL ILIAC ARTERY WAS COILED PRIOR TO THE EVAR. MEDICAL HISTORY IS UNKNOWN. ANEURYSM AND VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL NECK DIAMETER WAS 28.5MM. THE DISTAL NECK DIAMETER ABOVE THE ANEURYSM WAS 28MM. THE LENGTH OF THE AORTIC NECK WAS 30MM. THE DIAMETER OF THE ANEURYSM WAS 60MM. THE PROXIMAL NECK DIAMETER OF THE RIGHT ILIAC ARTERY WAS 20MM AND THE DISTAL RIGHT ILIAC DIAMETER WAS 23MM. THE RIGHT ACCESS VESSEL DIAMETER WAS 9MM. THE PROXIMAL NECK DIAMETER OF THE LEFT ILIAC ARTERY WAS 21MM AND THE DISTAL DIAMETER OF THE LEFT ILIAC ARTERY WAS 11MM. THE LEFT ACCESS VESSEL DIAMETER WAS 10MM. INTRA-OPERATIVELY IT WAS OBSERVED THAT THE RIGHT EXTERNAL ILIAC ARTERY (REIA) WAS DISSECTED. AN OCCLUSION WAS ALSO OBSERVED ON THE RIGHT LEG DUE TO THROMBUS. THE PHYSICIAN IMPLANTED A BARE STENT TO RESOLVE THE OCCLUSION AND RIGHT BLOOD FLOW WAS RESTORED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PHYSICIAN STATED THAT IT IS UNKNOWN WHEN THE DISSECTION OCCURRED DURING THE PROCEDURE. THE PATIENT IS FINE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184814 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01728339

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention