BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II ILIAC STENT GRAFT

    MDR report key: 6064284 · Received October 28, 2016

    Report

    Report Number
    2953200-2016-01877
    Event Type
    Death
    Date Received
    October 28, 2016
    Date of Event
    October 6, 2016
    Report Date
    November 17, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FILM EVALUATION RESULTS ARE: THE EXACT CAUSE OF THE REPORTED INACCURATE DELIVERY OF THE FIRST VALIANT STENT GRAFT LEADING TO PROXIMAL TYPE I ENDOLEAK, THE EXACT CAUSE OF THE RESIDUAL TYPE I ENDOLEAKS AFTER IMPLANT OF THE SECOND VALIANT AND ENDOANCHORS COULD NOT BE CONCLUSIVELY DETERMINED FROM THE PRE-IMPLANT 3D RECON REPORT PROVIDED. THE FILMS AT IMPLANT WERE NOT PROVIDED. IT IS POSSIBLE THAT IMPLANTING THE VALIANT STENT GRAFT IN THE INFRARENAL SPACE (OFF-LABEL) MAY HAVE CONTRIBUTED TO THE EVENT. THE ANGULATED INFRARENAL AORTIC NECK MAY HAVE ALSO CONTRIBUTED. THE PRE-IMPLANT 3D RECON SHOWED THAT THE INFRARENAL AORTIC NECK WAS MODERATELY ANGULATED, 51.3 DEG TO THE MID-AAA.

    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 IIS STENT GRAFT SYSTEM AND VALIANT STENT GRAFT SYSTEM WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 74 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. APTUS ENDOANCHORS WERE IMPLANTED AND TWO SENTRANT SHEATHS WERE USED DURING THE INDEX PROCEDURE. THE PATIENT HAD CHALLENGING ANATOMY AND PRESENTED WITH A 74 MM INFRARENAL AORTIC ANEURYSM. THE PROXIMAL NECK MEASURED 30MM IN DIAMETER AT THE LOWEST RENAL DILATING TO 36MM OVER APPROXIMATELY 10MM OF LENGTH. AT 5MM FROM THE LOWEST RENAL THE NECK DIAMETER IS 32MM, AT 10MM IT IS 36MM, AT 15MM IT IS 37MM AND AT 20MM IT IS 38 TO 39MM. THERE WAS MODERATE ANGULATION, MINIMAL CALCIUM AND NO THROMBUS. THE PATIENT WAS NOT SUITABLE FOR OPEN REPAIR AND THE PHYSICIAN DECIDED TO TREAT PATIENT OUTSIDE THE IFU. THE ENDURANT BIFURCATED STENT GRAFT AND LIMBS WERE DEPLOYED IN THE DISTAL AORTA NEAR THE AORTIC BIFURCATION. A 40/40/100 VALIANT CAPTIVIA STENT GRAFT WAS DEPLOYED BELOW LOWEST RENAL ARTERY AND ALL STENT GRAFTS WERE BALLOONED WITH ANOTHER MANUFACTURER'S BALLOON. AN ANGIOGRAM SHOWED THAT THE VALIANT CAPTIVIA HAD MOVED DISTALLY AND THERE WAS A TYPE L ENDOLEAK PRESENT. A 42/42/100 VALIANT STENT GRAFT WAS DEPLOYED PROXIMAL TO THE FIRST STENT GRAFT IMMEDIATELY BELOW THE LOWEST RENAL AND THE TYPE IA ENDOLEAK APPEARED LESSENED. THE PHYSICIAN ELECTED TO IMPLANT APTUS ENDOANCHORS; HOWEVER, THE TYPE LA ENDOLEAK PERSISTED. FURTHER ANGIOGRAM WAS PERFORMED REVEALING A SMALL TYPE I ENDOLEAK REMAINED. NO SIGNS OF RUPTURE WERE VISUALIZE AND THE PATIENT APPEARED STABLE AT THE END OF THE CASE. IT WAS REPORTED THAT ONE DAY POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED FROM THE PHYSICIAN THAT THE PATIENT BECAME UNSTABLE AGAIN AT SOME TIME AFTER THE PROCEDURE. THE PHYSICIAN STATED THAT A CT SCAN SHOWED A RUPTURE JUST ABOVE THE AORTIC BIFURCATION. THE PATIENT WAS TAKEN TO THE THEATRE FOR UNSUCCESSFUL OPEN PROCEDURE AND EXPIRED. THE PHYSICIAN STATED THE EXACT CAUSE OF THE RUPTURE COULD NOT BE DETERMINED. NO ADDITIONAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715804 ENDURANT II ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ETLW1624C124EE

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death| R