BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3944210 · Received July 18, 2014

    Report

    Report Number
    2953200-2014-01404
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: AORTIC NECK <(><<)> 10 MM IN LENGTH. EXACT EVENT AND IMPLANT DATES ARE UNKNOWN.

    Description of Event or Problem · 1

    THE FOLLOWING WAS RECEIVED FROM ANOTHER MANUFACTURER¿S ANCHOR REGISTRY. ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. 92 % OF ENDURANT PRIMARY CASES WERE WITH HOSTILE AORTIC NECKS. IT WAS REPORTED THERE WERE ACUTE TYPE IA ENDOLEAKS AND DISTAL MIS-DEPLOYMENT IN THE AORTIC NECK. THERE WAS A LATE TYPE IA ENDOLEAK NOTED AND STENT GRAFT MIGRATION. ENDURANT STENT GRAFTS WERE USED IN 21 PATIENTS WITH INFRARENAL NECK LENGTHS OF 0-5 MM AND IN 40 PATIENTS WITH LENGTHS OF 5-10 MM. THERE WERE 16 PATIENTS WITH INFRARENAL NECK LENGTHS OF 0-5 MM AND 35 PATIENTS WITH 5-10 MM. A SINGLE ENDURANT TYPE 1A ENDOLEAK WAS OBSERVED IN A SUBJECT WITH A 5 MM NECK, 38 DEGREES OF ANGULATION, AND 2MM AVERAGE NECK MURAL CALCIUM THICKNESS. THE SUBSEQUENT ENDOLEAK APPEARED TO ORIGINATE NEAR THIS LOCATION (OF THE MURAL CALCIUM). THE ENDO ANCHOR THAT POORLY PENETRATED THE AORTIC WALL WAS ALSO LOCATED JUST ANTERIOR TO THE CALCIUM. THE ENDURANT STENT GRAFT WAS PLACED 6 MM BELOW LOWEST MAIN RENAL TO PRESERVE AN ACCESSORY RENAL ARTERY. SUSPECTED UNINTENTIONAL STENT GRAFT DISTAL DEPLOYMENT. THE AORTIC NECK IS CONICAL IN SHAPE. THE DIAMETER AT TOP OF THE FABRIC WAS 27.5 MM VERSUS 23 MM AT THE LOWEST MAIN RENAL. THE IMPLANTED ENDURANT BIFURCATED STENT GRAFT WAS A 28 MM IN DIAMETER (WHICH IS UNDERSIZED, SHOULD HAVE USED A 32 MM). THE ENDOANCHOR AT THE 1 O¿CLOCK POSITION IS AT A 45-DEGREE ANGLE TO THE AORTIC WALL AND APPEARS TO POORLY PENETRATE THE AORTIC WALL. THIS WAS WHERE CALCIUM WAS LOCATED ON THE BASELINE CT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422385 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1