BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II BIFURCATED STENT GRAFT

    MDR report key: 8743404 · Received June 28, 2019

    Report

    Report Number
    9612164-2019-02574
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    March 6, 2019
    Report Date
    September 17, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    24-OFF-LABEL, UNAPPROVED OR CONTRAINDICATED USE: CHEVAR PROCEDURE, SHORT AORTIC NECK, JUXTARENAL ANEURYSM TREATED. JOURNAL ARTICLE DETAILS; TITLE: A VERY UNLUCKY INTRAOPERATIVE EVENT DURING A CHIMNEY TECHNIQUE FOR JUXTARENAL ANEURYSM EXCLUSION AUTHORS: JEREMIE JAYET, GAEL BOUNKONG, RAPHAELLE SYLVESTRE. CARDIOVASC INTERVENT RADIOL (2019) 42:1036¿1040. DOI: HTTPS://DOI.ORG/10.1007/S00270-019-02197-7. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    FDC CODE ADDED AT INVESTIGATION COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF A 56 MM JUXTARENAL AORTIC ANEURYSM. THE AORTIC NECK WAS 2 MM IN LENGTH HOWEVER IT WAS NOTED THAT A NEO-NECK OF 18 MM IN LENGTH COULD BE OBTAINED IN CASE OF STENT GRAFT SEALING JUST BELOW THE LEVEL OF THE SMA. DURING THE INDEX PROCEDURE, THE RIGHT AXILLARY ARTERY WAS APPROACHED THROUGH SURGICAL CUTDOWN WHILE BILATERAL PERCUTANEOUS FEMORAL ACCESSES WERE PERFORMED. AN 8-MM AXILLARY PROSTHETIC CONDUIT WAS CONSTRUCTED. THE CONDUIT WAS PUNCTURED ON TWO DIFFERENT SITES, AND TWO SHORT 7F SHEATHS WERE PLACED. AFTER SUCCESSFUL CATHETERIZATION OF THE RENAL ARTERIES USING A 100-CM NON-MEDTRONIC VERTEBRAL CATHETER AND A 0.0350 NON-MEDTRONIC GUIDEWIRE, A 0.0350 NON-MEDTRONIC ROSEN WIRE WAS POSITIONED DOWN TO EACH DISTAL RENAL ARTERY. TWO 70-CM 7 FRENCH NON-MEDTRONIC SHEATHS WERE BROUGHT IN THE RENAL ARTERIES. ON EACH SIDE, ONE 6 X 37 MM BALLOON EXPANDABLE NON-MEDTRONIC COVERED STENT WAS POSITIONED AT THE LEVEL OF THE RENAL ARTERY. THE SHEATHS WERE LEFT IN PLACE, AND THE RENAL STENTS WERE INITIALLY NOT DEPLOYED. THROUGH A RIGHT FEMORAL ACCESS, THE ENDURANT II MAIN STENT GRAFT BODY WAS ADVANCED OVER A NON-MEDTRONIC LUNDERQUIST WIRE. THE PROXIMAL PART OF THE GRAFT WAS POSITIONED JUST BELOW THE SMA OSTIUM, AND THE COVERING OF THE STENT GRAFT STARTED EXACTLY BELOW THE LEVEL OF THE RENAL ARTERIES. THE STENT GRAFT MAIN BODY AND ITS SUPRARENAL STENT WERE DEPLOYED. THE RENAL SHEATHS WERE REMOVED, AND THE COVERED RENAL STENTS WERE DEPLOYED IN A WAY THAT THE STENTS PROTRUDED THE COVERED FABRIC OF 2¿3 MM. TO PREVENT RENAL STENTS CROSSING AT THE LEVEL OF THE AORTIC STENT GRAFT LANDING ZONE, A GENTLE PULLBACK TRACTION WAS APPLIED WHILE THE BALLOONS WERE INFLATED IN THE RENAL STENTS. AFTER DEPLOYING THE RIGHT RENAL STENT, IT APPEARED THAT THE LONG SHEATH INSERTED THROUGH AN ARM ACCESS COULD NOT BE RETRIEVED OUT OF THE AORTA. THE BLOCKAGE WAS AT THE DISTAL PART OF THE SHEATH. USING HIGH-MAGNIFICATION IMAGES, IT WAS DISCOVERED TO BE TRAPPED BEHIND THE SUPRARENAL STENT BARBS OF THE ENDURANT II STENT GRAFT. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE SHEATH, THE STENT GRAFT WAS DISPLACED UPWARD, PARTIALLY COVERING THE SMA OSTIUM. A PARALLEL CATHETERIZATION OF THE RIGHT RENAL ARTERY WAS PERFORMED THROUGH A THIRD 7F SHEATH INTRODUCED IN THE AXILLARY CONDUIT. TO PREVENT SUPERIOR MESENTERIC ARTERY THROMBOSIS, A FOURTH 7F SHEATH WAS ADVANCED TO PERFORM A CHIMNEY ON THE SMA AND TWO 7 X 29 AND 8 X 29 MM NON-MEDTRONIC STENTS WERE DEPLOYED IN THE SMA. THE BALLOONS WERE LEFT IN PLACE IN THE TARGET VESSELS. THE PHYSICIAN FELT THAT THE REPAIR WAS SECURED, SINCE EACH OF THE THREE TARGET VESSELS WAS STENTED WITH ONE BALLOON IN PLACE IN EACH TARGET VESSEL. TO REMOVE THE BLOCKED SHEATH, SIMULTANEOUS BALLOONING OF THE THREE TARGET VESSELS AND THE ENDURANT II MAIN STENT GRAFT BODY WITH NON-MEDTRONIC BALLOONS PERMITTED TO EXERT A STRONG PULLBACK TRACTION ON THE BLOCKED SHEATH. THIS MANOEUVRE ALLOWED ITS REMOVAL. WHEN THE PHYSICIAN EXAMINED THE REMOVED SHEATH, IT APPEARED THAT ITS TWO DISTAL CENTIMETRES WERE MISSING. FLUOROSCOPY EXAMINATION OF THE AORTIC REPAIR DEMONSTRATED THAT THIS DISTAL EXTREMITY WAS LEFT BETWEEN THE SUPRARENAL STENTS OF THE ENDURANT II MAIN BODY. BOTH ANTEROPOSTERIOR AND MEDIOLATERAL VIEWS SHOWED THAT IT APPEARED FULLY STABILIZED BETWEEN THE AORTIC WALL AND THE SUPRARENAL STENT. THE PHYSICIAN DECIDED TO LEAVE IT IN PLACE. THE RENAL COVERED STENTS WERE PROXIMALLY EXTENDED WITH 7 X 37 MM NON-MEDTRONIC BALLOON EXPANDABLE CO STENTS DUE TO THE PROXIMAL STENT GRAFT MIGRATION. IT WAS ALSO DECIDED TO RELINE THE RENAL STENTS DISTALLY WITH NON-MEDTRONIC STENTS DUE TO A SLIGHT KINK ON BOTH SIDES. THE SECOND PART OF THE PROCEDURE COMPRISED A STANDARD ANEURYSM EXCLUSION USING AN AORTO-BI-ILIAC STENT GRAFT PRESERVING BILATERALLY THE INTERNAL ILIAC ARTERIES. COMPLETION ANGIOGRAPHY CONFIRMED THE SATISFACTORY ASPECT OF THE REPAIR WITH TARGET VESSELS PATENCY BUT THERE WAS A TYPE 2 ENDOLEAK THROUGH THE LUMBAR ARTERIES. POSTOPERATIVELY, THE PATIENT WAS KEPT IN THE VASCULAR SURGERY DEPARTMENT AND WAS DISCHARGED ON DAY 5 WITHOUT ANY UNANTICIPATED OR UNEXPECTED EVENTS. AT 12-MONTH FOLLOW- UP, THE PATIENT WAS HEALTHY AND ALL STENTS WERE PATENT ON THE CT SCAN. THE ANEURYSM WAS EXCLUDED AND REMAINED STABLE IN DIAMETER. NO EVENT RELATED TO THE PART OF THE SHEATH THAT WAS LEFT IN PLACE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538818 ENDURANT II BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ETBF2816C166EE

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention