BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA

    MDR report key: 3081389 · Received April 26, 2013

    Report

    Report Number
    2953200-2013-00785
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    November 8, 2004
    Report Date
    March 31, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION METHOD, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SEVERE CURVE IN THE AORTIC ARCH). (B)(4).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANT FOR THE ENDOVASCULAR TREATMENT OF A DESCENDING THORACIC AORTA ANEURYSM. THE VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS A SEVERE CURVE IN THE AORTIC ARCH. IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF AN ANEURYSM IN THE ASCENDING AORTA THAT WAS TREATED WITH ASCENDING AORTA AND ARCH REPLACEMENT WITH ELEPHANT TRUNK GRAFT PRIOR TO STENT GRAFT IMPLANTATION. THE PHYSICIAN IMPLANTED A TALENT (B)(4) PROXIMALLY INTO THE ELEPHANT GRAFT, AND DISTAL TO THE TAKEOFF OF THE GREAT VESSEL PATCH BYPASS. A SECOND DEVICE TALENT (B)(4) TALENT STENT GRAFT WAS DEPLOYED INTO THE DISTAL PORTION OF THE FIRST OF THE GRAFT. AN ANGIOGRAM REVEALED THAT THERE WAS A SLIGHT TYPE III ENDOLEAK, SEPARATION AT THE JUNCTION POINT AND THEREFORE PROXIMAL EXTENSION (B)(4) TALENT STENT GRAFT WAS IMPLANTED AND THE ENDOLEAK WAS RESOLVED. THERE WERE TWO MORE DEVICES DEPLOYED A (B)(4) DISTALLY. THE FINAL ANGIOGRAM REVEALED THAT THERE WAS COMPLETE EXCLUSION OF THE ANEURYSM AND GOOD PERFUSION TO THE CELIAC VESSEL. FIVE YEARS LATER THE PATIENT WAS TREATED WITH A (B)(4) FOR AN UNKNOWN REASON. TWO YEARS LATER THREE MORE DEVICES, (B)(4) WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR INTERVENTION FOR THE UNKNOWN TREATMENT. IT WAS REPORTED THAT ONE MONTH AGO THE PATIENT PRESENTED EMERGENTLY WITH SEVERE CHEST PAINS. THE PATIENT HAD BEEN LIFTING A 50 POUND PALLET AND THAT IS WHEN THE CHEST PAINS STARTED. THE CT REVEALED THAT THERE WAS A TYPE III ENDOLEAK, SEPARATION (EXACT DEVICES ARE UNKNOWN). THE PHYSICIAN ELECTED TO RELINE THE ENTIRE STENT GRAFT SYSTEM WITH (B)(4). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE REVIEW OF RETURNED FILMS POST-IMPLANT SHOW THAT MULTIPLE STENT GRAFTS HAVE BEEN IMPLANTED FROM THE PROXIMAL AORTIC ARCH, DISTALLY TO THE JUST PROXIMAL THE CELIAC ARTERY. NEAR THE DISTAL PORTION OF THE THORACIC ARCH THERE IS CONTRAST SEEN WITHIN THE ANEURYSM. THE ENDOLEAK APPEARED TO BE EMANATING FROM SEVERAL LOCATIONS; HOWEVER, THE TYPE AND CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED FROM THESE IMAGES. IMAGES AFTER RE-LINING OF THE ENTIRE STENT GRAFT WITH THREE LIMBS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182350 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA 108035Y

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention