BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 3884610 · Received June 19, 2014

    Report

    Report Number
    2953200-2014-01229
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, CONCLUSION: OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE (IMPLANTING DEVICE FOR JUXTARENAL AAA, AND SNORKEL VASCULAR BYPASS).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A JUNCTIONAL RENAL ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED THAT THE RIGHT COMMON ILIAC ARTERY WAS OCCLUDED WITH PREVIOUSLY PERFORMED FEM-FEM BYPASS. THE PHYSICIAN DECIDED TO COVER THE SMA AND BOTH RENAL ARTERIES WITH AN ENDURANT AUI DEVICE WHILE USING A SNORKEL TECHNIQUE. THE AUI STENT GRAFT WAS IMPLANTED COVERING BOTH THE SMA AND BOTH RENAL ARTERIES. DURING THE PROCEDURE THERE SOME EXTRAVASATION NOTICED FROM THE LEFT RENAL ARTERY. DURING FINAL ANGIOGRAM, A PROXIMAL TYPE 1A ENDOLEAK WAS PRESENT. THE PHYSICIAN DECIDED TO USE ENDO ANCHORS/STAPLES. FOUR ANCHORS/STAPLES WERE THEN PLACE AND FINAL ANGIOGRAM PREFORMED STILL SHOWING THE PROXIMAL TYPE 1A ENDOLEAK. NO OTHER ACTIONS WERE PERFORMED TO GRAFT FOLLOWING THE ANCHOR PLACEMENT. IT WAS REPORTED THAT LATER THAT DAY THE PATIENT BECAME HYPOTENSIVE AND EXPIRED. THE PHYSICIAN BELIEVES THAT THE LEFT RENAL ARTERY MAY HAVE RUPTURED DUE TO THE WIRE MANIPULATION DURING THE PROCEDURE. THE REVIEW OF RETURNED FILMS PRE-IMPLANT REVEALED THAT THE PROXIMAL NECK DIAMETER (FLOW LUMEN) MEASURED 29MM AT THE RIGHT RENAL ARTERY, AND 44 X 57MM AT THE TAKEOFF OF THE LOWEST LEFT RENAL ARTERY, WHICH WAS ALSO CALCIFIED NEAR ITS ORIGIN. THE MAXIMUM AAA DIAMETER WAS 6CM AND CONTAINED THROMBUS. THE RIGHT ILIAC WAS OCCLUDED, AND THE LEFT ILIAC WAS SEVERELY CALCIFIED AND TORTUOUS. IMAGES DURING IMPLANT AND POST-IMPLANT WERE NOT PROVIDED. THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK AND POSSIBLE LEFT RENAL ARTERY RUPTURE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360287 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04091953

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death