BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 5311559 · Received December 18, 2015

    Report

    Report Number
    2953200-2015-02390
    Event Type
    Injury
    Date Received
    December 18, 2015
    Date of Event
    December 2, 2015
    Report Date
    January 13, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). FILM EVALUATION RESULTS ARE: A REVIEW OF RETURNED PRE-IMPLANT CT¿S REVEALED THAT THE PATIENT HAD A 8.6CM MAX DIAMETER INFRARENAL AAA. THE PROXIMAL NECK FLOW LUMEN DIAMETER MEASURED 24 X 26MM JUST BELOW THE RENAL ARTERIES. THE INFRARENAL NECK WAS ANGULATED ~60 DEG R-L AND 55DEG A-P; RELATIVE TO THE DISTAL AORTA, AND THE SUPRARENAL ANGULATION WAS 60 L-R AND 40DEG P-A. THE AAA CONTAINED SIGNIFICANT THROMBUS; 3 ¿ 5CM DIAMETER FLOW LUMEN. THE DISTAL AORTIC DIAMETER MEASURED 35 X 15MM. THE RIGHT COMMON ILIAC ARTERY FLOW LUMEN DIAMETER RANGED FROM 11 ¿ 20 ¿ 15MM, AND THE LEFT COMMON ILIAC ARTERY DIAMETER RANGED FROM 13 ¿ 21MM. THE ILIACS WERE MODERATELY TORTUOUS <(>&<)> ACUTELY ANGULATED POSTERIORLY AT THEIR TAKE-OFF, AND CONTAINED THROMBUS AND MINIMAL CALCIFICATION. REVIEW OF ANGIO IMAGES DURING IMPLANT REVEALED THAT THE BIFURCATE WAS BROUGHT UP THE LEFT SIDE, AND POSITIONED JUST BELOW THE RENAL ARTERIES WITHIN THE ANGULATED PROXIMAL NECK. POST-DEPLOYMENT THE BIFURCATE STENT GRAFT PROXIMAL OD MEASURED 34MM AND THE AORTIC BODY WAS ANGULATED ~60DEG A-P RELATIVE TO THE DISTAL IPSI LIMB. THE CONTRA GATE OPENED IN THE A-P ORIENTATION. THE CONTRA LIMB WAS PLACED UP THE RIGHT SIDE AND DEPLOYED PROXIMALLY INTO THE GATE WITH 4CM OVERLAP. THE CONTRA LIMB WAS THEN SEEN EXTENDED WITH AN ADDITIONAL LIMB INTO THE RIGHT COMMON ILIAC ARTERY; HOWEVER, THERE WAS NO COMPONENT OVERLAP BETWEEN THE CONTRA LIMB AND EXTENSION. THE LEFT/IPSI LIMB WAS THEN EXTENDED WITH ANOTHER LIMB INTO THE LEFT COMMON ILIAC ARTERY. BALLOONING WAS PERFORMED WITHIN THE ENTIRE STENT GRAFT. A LIKELY JUNCTIONAL SEPARATION WAS THEN SEEN BETWEEN THE CONTRA LIMB AND EXTENSION, AND A LIMB WAS RELINED ACROSS THE JUNCTION RESOLVING THE ENDOLEAK. CONTRAST INJECTION ABOVE THE RENALS SHOWED THAT THE BIFURCATE HAD BEEN DEPLOYED ~15MM BELOW THE RENALS; NO SUPRARENAL ENTANGLEMENT OR OTHER OBVIOUS ISSUES OR ANY CLEAR ENDOLEAK WAS SEEN. AN ENDURANT AORTIC CUFF WAS THEN OBSERVED IMPLANTED ~15MM ABOVE THE BIFURCATE. THE SPINDLE FROM THE CUFF D-S WAS SEEN NEAR THE LEVEL OF THE CUFF SUPRARENAL STENTS, AND THE TIP WAS ~1CM ABOVE THE STENTS; THE D-S APPEARED TO BE STUCK (POSSIBLY ON THE SUPRARENAL STENT) AND COULD NOT BE RECAPTURED. A BALLOON WAS INFLATED NEAR THE STUCK D-S, AND THE NEXT ANGIO SHOWED THAT THE CUFF D-S HAS BEEN REMOVED AND THE CUFF WAS PARTIALLY COVERING BOTH RENAL ARTERIES. NO SUPRARENAL STENT ENTANGLEMENT WAS OBSERVED. A BALLOON WAS THEN SEEN INFLATED WITHIN THE CUFF IN AN ATTEMPT TO PULL THE DEVICE DOWN AND UNCOVER THE RENAL ARTERIES; HOWEVER, THE KIDNEYS DID NOT APPEAR TO BE COMPLETELY PERFUSED. FROM ABOVE THE STENT GRAFT THE LEFT <(>&<)> RIGHT RENAL ARTERIES WERE SEEN CANNULATED, BALLOONED, AND STENTED. FINAL ANGIO SHOWED FLOW WITHIN BOTH RENAL ARTERIES; THE STENT GRAFT WAS PATENT AND NO ENDOLEAK WAS OBSERVED. THE EXACT CAUSE OF THE EVENTS COULD NOT BE DETERMINED FROM THE FILMS PROVIDED. THE INACCURATE DELIVERY OF THE BIFURCATE MAY HAVE BEEN CAUSED BY THE REPORTED STRONG BLOOD PULSATION. THE CAUSE OF THE AORTIC CUFF DELIVERY SYSTEM GETTING CAUGHT ON THE SUPRARENAL STENTS, LEADING TO THE INABILITY TO RECAPTURE THE TAPERED TIP COULD NOT BE DETERMINED. IT IS ALSO POSSIBLE THAT THE ANGULATED PROXIMAL NECK MAY HAVE CONTRIBUTED TO THESE EVENTS. ATTEMPTS TO FREE THE STUCK D-S MAY HAVE LED TO THE INACCURATE CUFF PLACEMENT AND COVERAGE OF THE RENAL ARTERIES. THE LIKELY CAUSE OF THE CONTRA LIMB SEPARATION APPEARS DUE TO INADEQUATE DEVICE OVERLAP.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED 8.4CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTA HAD A SLIGHT INFRA-RENAL ANTERIOR ANGULATION WITH LITTLE TO NO SUPRARENAL ANGULATION. THE PROXIMAL AORTIC NECK MEASURED BETWEEN 27-29MM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN MENTIONED A STRONG PULSATION EFFECT THAT ULTIMATELY LED TO THE INACCURATE PLACEMENT OF THE ENDURANT BIFURCATE. THE BIFURCATE LANDED APPROXIMATELY 12 - 14MM FROM THE LOWEST RENAL ARTERY. THE PHYSICIAN SELECTED A 28MM ENDURANT II CUFF FOR FURTHER TREATMENT. DURING DEPLOYMENT OF THE CUFF, THE PHYSICIAN FULLY TURNED THE BACK END WHEEL TO RELEASE THE PROXIMAL END OF THE SUPRARENAL STENT. WHEN THE PHYSICIAN WENT TO MOVE THE DEVICE PROXIMALLY TO RECAPTURE THE SPINDLE IN THE TAPERED TIP, IT WAS UNSUCCESSFUL AS THE SPINDLE SEEMED TO GET CAUGHT ON ONE OF THE SUPRARENAL FIXATION STENTS. THE PHYSICIAN COULD NEITHER MOVE THE DEVICE PROXIMATELY NOR RECAPTURE THE TAPERED TIP DUE TO BOTH PARTS OF THE DEVICE GETTING CAUGHT ON THE FIXATION STENT. TORQUING THE DEVICE AS PER THE IFU WAS ATTEMPTED BUT THIS STILL PREVENTED RECAPTURE. AFTER INSERTION OF WIRES AND BALLOONS IN ORDER TO TRY AND FREE THE SPINDLE, THE TAPERED TIP WAS RECAPTURED EVENTUALLY; HOWEVER, THE ENDURANT CUFF WAS INACCURATELY DELIVERY RESULTED IN OCCLUSION TO BOTH RENAL ARTERIES. THE PHYSICIAN THEN INSERTED A BALLOON IN AN ATTEMPT TO PULL ALL DEVICES DISTALLY TO FREE THE GRAFT FROM THE RENAL ARTERIES BUT WAS INEFFECTIVE. EMERGENCY ACTIONS WERE TAKEN TO ENSURE FLOW TO BOTH RENAL ARTERIES AFTER A SURGICAL INTERVENTION. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE PATIENT IS DOING FINE; HOWEVER THE PATIENT IS DEPRESSED AND HAS LOST WEIGHT. THE PATIENT WILL BE MONITORED BY A PSYCHIATRY LIAISON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837126 ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ETBF2816C145EE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention