BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT (CT) AORTIC EXTENDER STENT GRAFT

    MDR report key: 4910745 · Received July 13, 2015

    Report

    Report Number
    2953200-2015-00996
    Event Type
    Death
    Date Received
    July 13, 2015
    Date of Event
    June 18, 2015
    Report Date
    July 23, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE EXAMINATION OF THE EXPLANTED DEVICES AND CLINICAL INFORMATION PROVIDED THE CAUSE OF THE STENT GRAFT MIGRATION LEADING TO PROXIMAL TYPE I ENDOLEAK AND RUPTURE COULD NOT BE CONFIRMED. NO DEVICE INTEGRITY ISSUES WERE OBSERVED ON THE BIFURCATE PROXIMAL SEAL ZONE AND NO FRACTURES WERE FOUND. AN AORTIC CUFF WAS OBSERVED PLACED WITHIN THE BIFURCATE; NO ISSUES WERE SEEN WITH THE CUFF. SEVERAL ABRASION AND CREASE FATIGUE TEARS WERE OBSERVED ON BOTH LIMBS; HOWEVER, IT IS UNLIKELY THAT THESE TEARS CONTRIBUTED TO THE MIGRATION. THE EXACT CAUSE OF THE HOLES COULD NOT BE DETERMINED, BUT LIKELY OCCURRED DUE TO ILIAC LIMB ANGULATION AND MAY HAVE OCCURRED AFTER THE DEVICE HAD MIGRATED INTO THE ANEURYSM SAC.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A TALENT AAA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 67 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY TO THE ER WITH BACK AND ABDOMINAL PAIN. IT WAS NOTED THAT THE ANEURYSM HAD RUPTURED. THE PHYSICIAN REPORTED THE PATIENT HAS AN EXISTING TALENT AAA STENT GRAFT THAT IS LYING AT THE BOTTOM OF THE ANEURYSM SAC AND THERE IS A RETROPERITONEAL HEMATOMA. THE PHYSICIAN ALSO STATED THEY WOULD LIKE TO TRY TO REPAIR ENDOVASCULARLY. AFTER THE ANATOMY WAS SIZED, THE PROXIMAL NECK DIAMETER WAS 37-40MM, THE PHYSICIAN DECIDED TO PERFORM OPEN SURGERY AND EXPLANT THE STENT GRAFTS. THE PHYSICIAN ALSO STATED THAT THE PATIENT HAS NEVER RETURNED FOR FOLLOW-UP SINCE THE ORIGINAL IMPLANT PROCEDURE. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS THE PROXIMAL NECK CONTINUED TO DILATE OVER TIME AND THE PATIENT LOST PROXIMAL SEAL. THE DEVICE WAS FOLDED IN HALF AT THE BOTTOM OF THE ANEURYSM SAC. THE DECISION WAS MADE TO EXPLANT ALL THE STENT GRAFTS AND ANOTHER MANUFACTURER¿S GRAFT (18X6 HEMASHIELD BIFURCATED GRAFT) WAS SEWN IN. THE PATIENT WAS HEMODYNAMICALLY UNSTABLE THROUGHOUT THE PROCEDURE AND HAD MINIMAL URINE OUTPUT. IT WAS LATER REPORTED THAT THE PATIENT EXPIRED. PER THE PHYSICIAN'S STATEMENT THE PATIENT DID NOT RECOVER FROM THE SURGERY AND THE PATIENT'S ANATOMY CONTRIBUTED TO THE DEVICE FAILURE; THEREFORE, THE PATIENT DID NOT RECOVER FROM THE EVENT. REVIEW OF CTA¿S 6 ½ YEARS POST-IMPLANT CONFIRMED THAT THE TALENT DEVICES WERE POSITIONED WITHIN THE BOTTOM OF THE AAA SAC; APPROXIMATELY 8CM BELOW THE RENALS. THE BIFURCATE HAS FOLDED OVER ITSELF NEAR THE FLOW DIVIDER. THE FILMS WERE NON-CONTRAST; THEREFORE STENT GRAFT PATENCY COULD NOT BE ASSESSED. THE PROXIMAL NECK RANGED IN DIAMETER FROM 34 ¿ 41MM, AND WAS ANGULATED APPROXIMATELY 60 DEGREE L-R TO THE DISTAL AORTA AND 80DEG A-P TO THE ILIAC LIMBS. THE IPSILATERAL LIMB WAS SEEN IMPLANTED INTO THE RIGHT COMMON ILIAC ARTERY AND THE CONTRA LIMB INTO THE LEFT COMMON ILIAC. THE DIAMETER OF THE DISTAL RIGHT LIMB MEASURED 20MM AND THE DIAMETER OF THE DISTAL LEFT/CONTRA LIMB MEASURED 16MM. THE MAX DIAMETER AAA MEASURED 7CM. A FEM-FEM BYPASS GRAFT WAS ALSO SEEN. NO OTHER STENT GRAFT ISSUES WERE OBSERVED. THE EXACT CAUSE OF THE STENT GRAFT MIGRATION COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED. EARLIER POST-IMPLANT FILMS WERE NOT AVAILABLE FOR REVIEW. IT APPEARS LIKELY THAT DISEASE PROGRESSION AND POSSIBLY ANEURYSM MORPHOLOGY CHANGES MAY HAVE CONTRIBUTED TO THE MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452913 TALENT (CT) AORTIC EXTENDER STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA AXF3636W26CT

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Death| R