BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 3815668 · Received May 16, 2014

    Report

    Report Number
    2953200-2014-01004
    Event Type
    Death
    Date Received
    May 16, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 48.7X51.7 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK DIAMETER WAS 23 MM, THE DISTAL NECK DIAMETER WAS 24.3 MM, WITH A LENGTH OF APPROXIMATELY 18-20 MM, WITH AN ANGULATION OF 60 DEGREES. THE NECK WAS DOUBLE ANGLED, WITH MILD THROMBUS. THE AORTA AND ILIAC ARTERIES WERE DESCRIBED AS BEING VERY TORTUOUS. THE COMMON ILIAC ARTERIES WERE CALCIFIED, ESPECIALLY THE LEFT COMMON ILIAC ARTERY. THE COMMON FEMORAL ARTERIES WERE ALSO CALCIFIED. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO IMPLANT THE STENT GRAFT. THE PROCEDURE WAS COMPLETED, BUT A FINAL ANGIOGRAM REVEALED WHAT WAS BELIEVED TO BE A TYPE IA ENDOLEAK. THE PROXIMAL SEAL ZONE OF THE BIFURCATE WAS RE-BALLOONED USING ANOTHER MANUFACTURER'S DEVICE, AND THE PATIENT'S BLOOD PRESSURES DROPPED QUICKLY. THE PATIENT WAS STABILIZED, AND THE PHYSICIAN DECIDED TO IMPLANT A CUFF TO RESOLVE WHAT WAS STILL BELIEVED TO BE A TYPE IA ENDOLEAK. AFTER THE CUFF WAS IMPLANTED, THE PATIENT'S BLOOD PRESSURES C ONTINUED TO FLUCTUATE. THE PHYSICIAN DECIDED TO CONVERT TO AN OPEN PROCEDURE TO FIND THE SUSPECTED LEAK. THE PATIENT LATER EXPIRED, AND IT WAS DETERMINED THAT THERE WAS A DISSECTION THAT EXTENDED FROM JUST PROXIMAL TO THE STENT GRAFT TO THE TRANSVERSE ARCH. THE PHYSICIAN NOTED THAT THERE WAS A PROXIMAL SEAL ON THE IMPLANTED CUFF. THE PHYSICIAN STATED THAT THE PRODUCT WAS IN NO WAY RESPONSIBLE FOR THE PATIENT DEATH, BUT THE PHYSICIAN DOES NOT FEEL THE DISSECTION WAS PRESENT PRE-OP. A REVIEW OF PRE-IMPLANT IMAGES REVEALED A SEVERELY ANGULATED PROXIMAL NECK WHICH WAS CALCIFIED. THE NECK WAS ANGULATED APPROX 110DEG RT-LT; OFF-LABEL USE. THE NECK DIAMETER VARIED FROM APPROX 23MM JUST BELOW THE RENALS, TO 25MM JUST ABOVE THE AAA. AT THE ACUTELY ANGULATED BEND, THE DIAMETER OF THE NECK WAS 16MM. THE MAX AAA DIAMETER WAS 5CM. THE TAKE-OFF OF BOTH ILIAC ARTERIES WERE ACUTELY ANGULATED 110 DEG LT-RT; RELATIVE TO THE AAA CENTERLINE, AND THE ILIACS WERE SEVERELY CALCIFIED. IMAGES DURING AND POST-IMPLANT WERE NOT PROVIDED. IT IS LIKELY THAT THE SEVERELY PROXIMAL NECK CONTRIBUTED TO THE PROXIMAL TYPE I ENDOLEAK. THE CAUSE OF THE DISSECTION COULD NOT BE DETERMINED; HOWEVER, THE SUPRARENAL AORTA/AND DISTAL THORACIC APPEARED VERY DISEASED WITH THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293314 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04121323

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Death