BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CAPTIVIA

    MDR report key: 3143454 · Received June 3, 2013

    Report

    Report Number
    2953200-2013-01047
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 4, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED: DISEASE PROGRESSION); CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED: DISEASE PROGRESSION).

    Additional Manufacturer Narrative · 1

    METHOD - (FILMS), RESULTS: INCORRECT TECHNIQUE/PROCEDURE (IMPLANTING SAME SIZE IN DIAMETER STENT GRAFTS NOT ALLOWING FOR OVERSIZING OF THE GRAFTS INSIDE OF ONE ANOTHER), CONCLUSION: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (IMPLANTING SAME SIZE IN DIAMETER STENT GRAFTS NOT ALLOWING FOR OVERSIZING OF THE GRAFTS INSIDE OF ONE ANOTHER).

    Description of Event or Problem · 1

    A TALENT CAPTIVIA STENT GRAFT SYSTEM WAS USED FOR THE TREATMENT OF AN 8 CM IN DIAMETER THORACIC AORTA ANEURYSM. THERE WAS DEBRANCHING PRIOR TO IMPLANTATION OF THE STENT GRAFT SYSTEM. VESSEL MORPHOLOGY WAS REPORTED AS THERE IS A KINK IN THE STENT GRAFT WHERE THE ALLEGED TYPE III ENDOLEAK, FABRIC IS PRESENT. THE ANEURYSM IS CURRENTLY 13 CM IN DIAMETER. THE PATIENT RETURNED FOR ALL REGULAR FOLLOW UPS, THERE WERE NO ISSUES. THE PATIENT PRESENTED EMERGENTLY WITH PAIN. THE RECENT CT DEMONSTRATED THAT THERE WAS A TYPE III ENDOLEAK, FABRIC IS ON THE LESSER CURVE OF THE ARCH, DUE TO DISEASE PROGRESSION. THE PHYSICIAN ELECTED TO RELINE THE STENT GRAFT WITH ANOTHER MANUFACTURER¿S STENT GRAFT. THE TYPE III ENDOLEAK, FABRIC WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. POST-IMPLANT FILMS SHOWED THAT THE STENT GRAFT WAS IMPLANTED FROM THE ASCENDING THORACIC, DISTALLY INTO THE DESCENDING AORTA. THE AORTIC ARCH DID NOT APPEAR EXCESSIVELY ANGULATED. CONTRAST WAS SEEN WITHIN THE ANEURYSM SAC NEAR THE DISTAL END OF THE ARCH AS THE STENT GRAFT DESCENDED. THE SITE OF THE ENDOLEAK APPEARED TO BE IN AN AREA OF STENT GRAFT OVERLAP; NEAR THE MARKER BANDS. IT COULD NOT BE DETERMINED IF THE ENDOLEAK WAS A TYPE III FABRIC OR TYPE III JUNCTIONAL, AND MAY HAVE BEEN FROM MULTIPLE SOURCES. NO OBVIOUS STENT GRAFT KINK OR OTHER ISSUES WERE OBSERVED. THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED, AND EARLIER FOLLOW-UP IMAGES WERE NOT AVAILABLE TO ASSESS FOR ANY POSSIBLE STENT GRAFT IN-VIVO CONFIGURATION CHANGES OVER THE IMPLANT DURATION.

    Description of Event or Problem · 1

    REVIEW OF THE RETURNED FILMS WAS COMPLETED. THE FOUR GRAFTS IMPLANTED ARE TALENT THORACIC STENT GRAFTS. THERE IS A TYPE III ENDOLEAK IN THE STENT GRAFT, THOUGH THERE IS NO SIGN OF THE REPORTED KINK NEAR THE LEAK LOCATION. THERE IS NO ASSIGNABLE CAUSE FOR THE TYPE III ENDOLEAK, HOWEVER IT MAY BE RELATED TO THE IMPLANTATION OF THE SAME SIZE IN DIAMETER STENT GRAFTS NOT ALLOWING FOR OVERSIZING OF THE GRAFTS INSIDE OF ONE ANOTHER. THE PHYSICIAN IMPLANTED THE STENT GRAFT IN THE ARCH FIRST, AND THEN IMPLANTED ONE GRAFT PROXIMAL AND TWO GRAFTS DISTAL TO IT. THE TYPE III ENDOLEAK SEEMS TO BE AT THE DISTAL EDGE OF THE FIRST GRAFT IMPLANTED IN THE ARCH. THREE OF THE FOUR GRAFTS ARE ALL 46MM, NOT ALLOWING FOR OVERSIZING OF THE GRAFTS INSIDE OF ONE ANOTHER, THERE MIGHT NOT BE A SEAL BETWEEN THE GRAFTS, ALLOWING THE TYPE III ENDOLEAK TO DEVELOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245383 TALENT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00557040

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention