BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II AUI STENT GRAFT

    MDR report key: 6056144 · Received October 25, 2016

    Report

    Report Number
    2953200-2016-01856
    Event Type
    Death
    Date Received
    October 25, 2016
    Date of Event
    October 21, 2016
    Report Date
    January 5, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN ENDURANT II AORTO-UNI-ILIAC STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD HEAVY CALCIUM AT THE LEVEL OF THE RENAL ARTERIES. IT WAS REPORTED THAT, DURING THE INDEX PROCEDURE, THE PHYSICIAN INTENDED TO LAND THE STENT GRAFT APPROXIMATELY 1 CM DISTAL TO THE RENAL ARTERIES. WHEN THE PHYSICIAN PULLED THE ENDURANT II STENT GRAFT DOWN, IT EVENTUALLY SETTLED BELOW THE CALCIUM. HOWEVER, THE CALCIUM CONSTRAINED THE SUPRARENAL STENT AND IT DID NOT FULLY DEPLOY. THE PHYSICIAN WAS UNABLE TO MOVE THE DELIVERY SYSTEM OR STENT GRAFT PROXIMALLY OR DISTALLY. THE PHYSICIAN ELECTED TO PERFORM THE REAR HANDLE DISASSEMBLY TECHNIQUE. HOWEVER, THE PHYSICIAN WAS STILL UNABLE TO MOVE THE STENT GRAFT PROXIMALLY OR DISTALLY. THE PHYSICIAN THEN ATTEMPTED TO BALLOON THE CALCIFIED AREA WITHOUT SUCCESS. THE PHYSICIAN ADVANCED THE 18FR SENTRANT SHEATH COVERING THE DELIVERY SYSTEM AND INTO THE DISTAL END OF THE AUI STENT GRAFT. THE PHYSICIAN THEN ELECTED TO ADVANCE THE DELIVERY SYSTEM GRAFT COVER INTO THE BODY OF THE STENT GRAFT. AFTER ADVANCING THE GRAFT COVER, THE DELIVERY SYSTEM WAS ABLE TO BE ADVANCED PROXIMALLY INTO THE AORTA AND THE TAPERED TIP WAS ABLE TO BE RECAPTURED. THE PHYSICIAN THEN SUCCESSFULLY REMOVED THE DELIVERY SYSTEM FROM THE PATIENT. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE THE PATIENT ANATOMY OF SMALL VESSELS AND HEAVY CALCIFICATION. ONE DAY POST INDEX PROCEDURE, THE PATIENT HAD BLOODY STOOLS. THE PHYSICIAN ELECTED TO REMOVE THE TRANSVERSE COLON. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS LIKELY DUE TO AN EMBOLIZATION THAT OCCURRED FROM THE INDEX PROCEDURE. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: THE PHYSICIAN STATED THE BOWEL TWISTING WAS NOT RELATED TO THE DEVICE OR PROCEDURE, IT WAS DUE TO THE TWISTING OF BOWEL IN THE AREA OF THE ANASTOMOSIS WHICH CAUSED THE BOWEL TO INFARCT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO A BOWEL INFARCT. THE BOWEL HAD TWISTED 180 DEGREES AND WAS THE CAUSE OF THE INFARCT. NO ADDITIONAL CLINICAL SEQUALE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705094 ENDURANT II AUI STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ETUF2814C102E

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| R