BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3112402 · Received May 14, 2013

    Report

    Report Number
    2953200-2013-00891
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 6, 2011
    Report Date
    April 19, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: STENT GRAFT OCCLUSION. CAUSE OF EVENT IS UNKNOWN. CONCLUSION: STENT GRAFT OCCLUSION. CAUSE OF EVENT IS UNKNOWN.

    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. A 50.6 MM IN DIAMETER FUSIFORM ABDOMINAL AORTIC ANEURYSM WAS REPORTED WITH AN INFRA-RENAL ANGLE OF 28.7 DEGREES. PROXIMAL AORTA WAS 22.5 MM IN DIAMETER AND 14.7 MM IN LENGTH. DISTAL AORTA WAS 29.6 MM IN DIAMETER. RIGHT ILIAC ARTERY WAS 15.5 MM, 14.5 MM, 16.9 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 15.4 MM, 17.6 MM, AND 12.7 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 11.1 MM, AND 11.3 MM IN DIAMETER, RESPECTIVELY. THE RIGHT ILIAC ARTERY WAS MILDLY TORTUOUS AND LEFT ILIAC ARTERY WAS MODERATELY TORTUOUS. THE CIRCUMFERENTIAL AORTIC MURAL THROMBUS/CALCIFICATION AT THE PROXIMAL NECK WAS 30%. IT WAS REPORTED THAT THE PATIENT HAD A FEMORO-DISTAL BYPASS DUE TO ARTERIAL OCCLUSION. THE STENT GRAFT OCCLUDED REQUIRING ADDITIONAL ANGIOPLASTY. THE INVESTIGATOR ASSESSMENT STATES THAT THE EVENT IS NOT DEVICE OR PROCEDURE RELATED. THE EVENT RESOLVED. A MONTH LATER THE PATIENT HAD SFA ANGIOPLASTY DUE TO ARTERIAL OCCLUSION. THE ANGIOPLASTY WAS UNSUCCESSFUL. THE INVESTIGATOR ASSESSMENT STATES THAT THE EVENT IS NOT RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT DEVELOPED A RIGHT GROIN HEMATOMA POST ANGIOPLASTY; WHICH RESOLVED. THE INVESTIGATOR ASSESSMENT STATES THAT THE EVENT IS NOT RELATED TO THE DEVICE OR PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT'S CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212558 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00491880

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention