BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II BIFURCATED STENT GRAFT

    MDR report key: 6167265 · Received December 12, 2016

    Report

    Report Number
    2953200-2016-02092
    Event Type
    Death
    Date Received
    December 12, 2016
    Date of Event
    November 14, 2016
    Report Date
    April 27, 2017
    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

    CONCLUSION: FAILURE TO FOLLOW INSTRUCTIONS (DID NOT USE BAIL OUT TECHNIQUE).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    FILM EVALUATION SUMMARY: THE PRE-IMPLANT ANATOMY INFORMATION AND ADDITIONAL FILMS AT IMPLANT WERE NOT PROVIDED. THE EXACT CAUSE OF EVENTS COULD NOT BE CONCLUSIVELY DETERMINED FROM THE FOUR STILL IMAGES PROVIDED. THE IMAGES PROVIDED SHOWED THAT THE SPINDLE APPEARED TO HAVE GOTTEN CAUGHT ON THE SUPRARENAL STENT LOCATED ON THE RIGHT SIDE. THE INFRARENAL AORTIC NECK WAS MODERATELY ANGULATED. THE AORTIC NECK ANGULATION MAY HAVE CONTRIBUTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE COMPLAINT COULD NOT BE CONFIRMED SINCE THE EVENT TOOK PLACE IN VIVO AND THE COMPLETE DELIVERY SYSTEM WAS NOT RETURNED. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, PER FILM REVIEW, THE MODERATE VESSEL TORTUOSITY LIKELY CONTRIBUTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE BACK-END WHEEL WORKED BUT IT DID NOT TRANSLATE MOVEMENT TO THE TIP, AND THE PHYSICIAN DID NOT FOLLOW THE BAIL OUT TECHNIQUE PRIOR TO CONVERSION.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 53 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PATIENT MORPHOLOGY WAS REPORTED AS THERE WAS SEVERE TORTUOSITY, NO CALCIFICATION, AND NO STENOSIS. THERE WAS NO DAMAGE REPORTED TO THE OUTER PACKAGING AND NO ISSUES WITH REMOVING THE DEVICE FROM THE TRAY. IT WAS REPORTED THAT THE ENDURANT II STENT GRAFT WAS ADVANCED TO THE INTENDED LANDING ZONE AND IMPLANTED WITHOUT ISSUE. HOWEVER UPON REMOVAL THE DELIVERY SYSTEM IT BECAME CAUGHT ON THE STENT GRAFT. THE PROXIMAL END OF THE SUPRARENAL STENT WAS RELEASED BUT THE PHYSICIAN WAS UNABLE TO REMOVE THE DELIVERY SYSTEM AS THE SPINDLE WAS UNABLE TO BE RECAPTURED INTO THE TAPERED TIP. THE PHYSICIAN ELECTED TO PERFORM OPEN SURGICAL REPAIR, REMOVING THE SECTION OF THE AORTA WHERE THE DELIVERY SYSTEM WAS CAUGHT. SUBSEQUENTLY, TWO DAYS POST PROCEDURE THE PATIENT EXPERIENCED POSTTRANSFUSION, COLIC NECROSIS AND EXPIRED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS RELATED TO THE DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT ACCESS WAS GAINED THROUGH BOTH FEMORAL ARTERIES AND ANOTHER MANUFACTURER'S CLOSURE DEVICE WAS USED. AN 11 FRENCH INTRODUCER SHEATH WAS PLACED ON THE RIGHT AND LEFT SIDE. A PIGTAIL CATHETER WAS THEN PLACED ON THE LEFT SIDE. THE BIFURCATED STENT GRAFT WAS PLACED AND ITS POSITION WAS VERIFIED. THE SUPRA RENAL PINS WERE RELEASED AND THE DELIVERY SYSTEM WAS ADVANCED PROXIMALLY. THE BACK-END WHEEL WAS THEN ROTATED TO RECAPTURE THE SPINDLE BUT THIS ACTION WAS INEFFECTIVE. AN ATTEMPT WAS MADE TO GET THE DELIVERY SYSTEM DOWN BY ROTATION BUT IT WAS CATCHING ON THE STENT GRAFT. AN UNSUCCESSFUL ATTEMPT TO ADVANCE THE STENT GRAFT WAS ALSO MADE. AFTER SEVERAL ATTEMPTS TO REMOVE THE DELIVERY SYSTEM THE PHYSICIAN DECIDED TO PERFORM A SURGICAL CONVERSION. IT WAS NOTED THAT A CROSS SECTION OF SUB-RENAL AORTA UNDER ACTIVE BLEEDING CONDITIONS AS WELL AS A SECTION OF THE DELIVERY CATHETER WERE NECESSARY. PROXIMAL ANASTOMOSIS WAS PERFORMED AS WELL AS TERMINO-TERMINAL ANASTOMOSIS. THROMBOSIS WAS THEN NOTICED IN THE SUB-RENAL AORTA AND AN UNSUCCESSFUL THROMBECTOMY WAS ATTEMPTED. THE ANASTOMOSIS WAS DISASSEMBLED AND ANOTHER MANUFACTURER'S PROSTHETIC BODY WAS USED. REPAIR OF THE ANEURYSM, ANASTOMOSIS, AND LIGATURE OF THE PRIMITIVE ILIAC ARTERIES WAS COMPLETED. IT WAS ALSO NOTED THAT THROMBUS EXTRACTION IN THE FEMORAL BIFURCATION WAS ALSO PERFORMED AS WELL AS A MASSIVE BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816407 ENDURANT II BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ETBF3216C166EE

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death| R