BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 3930271 · Received July 11, 2014

    Report

    Report Number
    2953200-2014-01381
    Event Type
    Death
    Date Received
    July 11, 2014
    Date of Event
    June 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AORTIC NECK GREATER THAN 60 DEGREE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE A TYPE IA ENDOLEAK WAS NOTED. A CUFF WAS ADDED FROM THE LEFT SIDE AS THERE WAS A NECK BUBBLE JUST DISTAL TO THE RIGHT RENAL ARTERY. THE LEFT RENAL WAS THE TARGET. THE CUFF SEALED A FEW MILLIMETERS HIGHER AND BALLOONING WAS PERFORMED. THE FINAL ANIO REVEALED THAT THE ENDOLEAK WAS RESOLVED. REVIEW OF PRE-IMPLANT CTA'S REVEALED THAT THE INFRARENAL AORTA WAS SEVERELY TORTUOUS FROM THE RENALS TO THE ILIAC ARTERIES. THE PATIENT ALSO HAD CURVATURE OF THE SPINE. THE PROXIMAL NECK WAS ANGULATED 110 DEG RT-LT AND 90 DEG A-P; RELATIVE TO THE AAA CENTERLINE, AND THE RIGHT ILIAC TAKEOFF WAS ANGULATED 90DEG LT-RT; RELATIVE TO THE AAA CENTERLINE. THE PROXIMAL NECK DIAMETER WAS 26 - 28MM. THE AAA WAS BI-LOBED; THE PROXIMAL AAA JUST BELOW THE NECK MEASURED APPROXIMATELY 4CM MAXIMUM, NARROWED DOWN TO 3CM, AND THEN INCREASED TO 5.5CM MAX DIAMETER AT THE LOWER (PRIMARY) AAA. THE PROXIMAL NECK AND AAA WERE CALCIFIED. THE ILIAC ARTERIES WERE EXTENSIVELY CALCIFIED BILATERALLY. THE RCIA DIAMETER WAS 14-15MM AND THE LCIA DIAMETER WAS 11-16MM. CTA'S 1 WEEK POST-IMPLANT REVEALED THAT THE BIFURCATE WAS POSITIONED WITHIN THE ANGULATED NECK, JUST BELOW THE LEVEL OF THE RENALS. THE TOP OF THE SUPRARENAL STENTS ARE POSITIONED APPROX 1.5CM BELOW THE SMA. THE IPSI LIMB AND EXTENSION WERE IMPLANTED INTO THE RIGHT COMMON ILIAC. THE CONTRA LIMB WAS POSITIONED WITHIN THE LEFT COMMON ILIAC. CONTRAST IS SEEN OUTSIDE THE STENT GRAFT COMING FROM A LIKELY RUPTURE NEAR THE PROXIMAL NECK; THE RUPTURE MAY BE CONTAINED. THE LOCATION OF THE RUPTURE IS NEAR THE BIFURCATE PROXIMAL STENT GRAFT MARGIN, AND CONTRAST IS SEEN EXTENDING PROXIMALLY TO JUST ABOVE THE LEVEL OF THE SUPRARENAL STENTS, AND DISTALLY TO NEAR THE LEVEL OF THE BIFURCATE FLOW DIVIDER. THE STENT GRAFT PROXIMAL OD IS 33MM. THERE IS POSSIBLE OVERLAPPING OF 2 OF THE SUPRARENAL STENTS; NO OTHER STENT GRAFT ISSUES COULD BE SEEN, AND BOTH LIMBS APPEAR PATENT. THE CAUSE OF THE AORTIC RUPTURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.5CM ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WAS NOT REPORTED. APPROXIMATELY SEVEN DAYS POST EVAR REPAIR IT WAS REPORTED THAT THE PATIENT RUPTURED AND THE PATIENT EXPIRED. THE CAUSE OF THE RUPTURE IS UNKNOWN; HOWEVER, THE RUPTURE WAS ABOVE THE STENT GRAFT. THE CAUSE OF DEATH WAS DUE TO THE RUPTURE.

    Description of Event or Problem · 1

    FURTHER INVESTIGATION REVEALED THAT THE RUPTURE APPEARS TO ORIGINATE RIGHT UNDER A SET OF ANCHOR PINS ON THE SUPRARENAL STENT. IN THE REGION OF THE RUPTURE THERE ARE FIVE SETS OF ANCHOR PINS DUE TO THE IMPLANTATION OF AN AORTIC EXTENSION DURING THE INITIAL PROCEDURE. THE RUPTURE SITE IS ALSO LOCATED ON THE OUTSIDE OF THE VESSEL WALL WHERE THE SUPRARENAL STENT AND GRAFT WILL EXPAND LESS DUE TO THE BIAS OF THE DELIVERY SYSTEM DURING IMPLANTATION. IT WAS NOTED A MEASUREMENT INCREASE IN VESSEL DIAMETER AT THE RENAL ARTERIES FROM ~24 MM PRE IMPLANT SCAN TO ~35 MM POST IMPLANT. IT IS UNKNOWN IF THE DIAMETER INCREASE OCCURRED PRIOR TO THE IMPLANTATION OF THE GRAFT. THE PATIENT HAD TORTUOUS ILIAC ARTERIES AND A VERY SHARP BEND IN THE ANEURYSM. THE ANEURYSM NECK WAS FAIRLY STRAIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406543 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04247137

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Death| R