BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2842708 · Received November 21, 2012

    Report

    Report Number
    2953200-2012-02254
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    June 14, 2015
    Report Date
    June 14, 2015
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: (FILM). RESULTS: INHERENT RISK OF PROCEDURE (DISSECTION, CONVERSION TO OPEN REPAIR); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SEVERELY ANGULATED AORTIC NECK); INCORRECT TECHNIQUE/PROCEDURE (TREATMENT OF A PATIENT WITH AORTIC NECK ANGULATION GREATER THAN 60 DEGREES). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (SEVERELY ANGULATED AORTIC NECK); OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (TREATMENT OF A PATIENT WITH AORTIC NECK ANGULATION GREATER THAN 60 DEGREES).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 4.0 CM DIAMETER X 10.8 CM LENGTH ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE PROXIMAL AORTIC NECK WAS 20 MM IN DIAMETER AND DISTAL AORTIC NECK WAS 17 X 23 MM IN DIAMETER. THE RIGHT ILIAC ARTERY WAS 20 MM IN DIAMETER THE LEFT ILIAC WAS 17 TO 30 MM IN DIAMETER. IT WAS REPORTED THAT TWO DAYS POST IMPLANT A DISSECTION WAS NOTED FROM ABOVE RENAL ARTERIES TO THE ASCENDING THORACIC AORTA. THE PHYSICIAN PERFORMED AN OPEN SURGERY AND AORTA REPLACEMENT WAS PERFORMED FROM THE ASCENDING AORTA TO AORTIC ARCH. THE PHYSICIAN COMMENTED THAT THE RELATION WITH THE ENDURANT STENT GRAFT IS UNKNOWN. AFTER THE OPEN SURGERY, THE PATIENT WAS FINE. THE PHYSICIAN DOES NOT KNOW THE CAUSE OF THE DISSECTION. PRE-IMPLANT CTAS WERE REVIEWED AND SHOW A SEVERELY ANGULATED PROXIMAL NECK; >90DEG. ABOVE THE RIGHT RENAL, THE AORTIC DIAMETER (FLOW LUMEN) IS 22 X 25MM, AND BELOW THE RIGHT RENAL IS 20-21MM. BEGINNING JUST BELOW THE LOWEST LEFT RENAL, THE AORTA COURSES HORIZONTAL FOR 5CM; THE DIAMETER IS 18MM. JUST ABOVE THE AAA THE VERTICAL NECK DIAMETER IS 16X20MM. THERE IS MINIMAL CALCIFICATION SEEN. THE AAA MAX DIAMETER IS 4 X 6CM, AND THE DISTAL AORTA DIAMETER IS 3CM. THE ILIAC ARTERIES ARE LARGE, MILDLY TORTUOUS WITH MINIMAL CALCIFICATION. THERE IS NO PRE-EXISTING DISSECTION OBSERVED. POST-IMPLANT FILMS WERE NOT PROVIDED; THE CAUSE OF THE REPORTED DISSECTION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. AN ARTIFICIAL VESSEL REPLACEMENT WAS PERFORMED USING A Y-GRAFT AS THE ANEURYSM DIAMETER ENLARGED DUE TO TYPE 1A ENDOLEAK. THE TYPE 1A ENDOLEAK SEEMS TO HAVE DEVELOPED ON THE PROXIMAL SIDE DUE TO MIGRATION ON THE DISTAL SIDE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01690428

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention