BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC THORACIC STENT GRAFT SYSTEM

    MDR report key: 3024364 · Received March 27, 2013

    Report

    Report Number
    2953200-2013-00549
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 19, 2014
    Report Date
    February 19, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSION: (ENDOLEAK, STENT GRAFT MIGRATION, ANEURYSM RUPTURE). (UNKNOWN CAUSE OF EVENT).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM APPROXIMATELY ONE YEAR AGO. AT THE INDEX PROCEDURE THE FIRST STENT GRAFT WAS DEPLOYED COVERING THE LSA. POST IMPLANT THERE WAS A PROXIMAL TYPE I ENDOLEAK. A SECOND STENT GRAFT WAS IMPLANTED PROXIMALLY; HOWEVER, A DISTAL TYPE I ENDOLEAK WAS NOTED. NO FURTHER INTERVENTION WAS PERFORMED. APPROXIMATELY TWO MONTHS AGO THE PATIENT PRESENTED AT THE HOSPITAL AND A CT SCAN WAS PERFORMED AND SHOWED A RUPTURED ANEURYSM. IT WAS CONFIRMED THAT DURING THE PATIENT'S FOLLOW-UP APPOINTMENTS THERE WAS ANEURYSM EXPANSION SEEN EVERY 3 MONTHS. THE PATIENT ALSO HAD LOW BLOOD PRESSURE OF 70HG. THE DECISION WAS MADE TO PERFORM OPEN SURGICAL REPAIR AND THE STENT GRAFT WAS FOUND TO HAVE MIGRATED TO THE BRACHIOCEPHALIC ARTERY. A SYNTHETIC GRAFT WAS SUTURED TO THE TALENT STENT GRAFT AND THE ANEURYSM WALL. ADDITIONALLY THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH ENDURANT STENT GRAFTS ON AN UNKNOWN DATE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEMOPTYSIS AND THERE WAS ENLARGEMENT OF THE ANEURYSM AND THE PATIENT CONTINUES TO BE HOSPITALIZED. THE PHYSICIAN COMMENTED THAT THE HEMOPTYSIS SEEMED TO BE COMING FROM THE ANASTOMOSIS SITE OF THE SYNTHETIC VESSEL AND TALENT STENT GRAFT. THE PATIENT HAS BEEN PSYCHIATRICALLY HOSPITALIZED DUE TO SCHIZOPHRENIA. AFTER THE HEMOPTYSIS THE PATIENT HAS BEEN IN A LULL. NO FURTHER INFORMATION WAS PROVIDED. REVIEW OF RETURNED FILMS 18 MONTHS POST-IMPLANT REVEALED THAT THE STENT GRAFTS WERE IMPLANTED FROM THE BRACHIOCEPHALIC, EXTENDING DISTALLY INTO THE MID-THORACIC AORTA. THE GREAT VESSELS HAD BEEN BYPASSED. THERE WAS A TAA WHICH MEASURED APPROXIMATELY 9CM MAXIMUM DIAMETER. NO ENDOLEAK COULD BE CONFIRMED. AN ENDURANT STENT GRAFT SYSTEM WAS ALSO SEEN IMPLANTED IN THE INFRA-RENAL AORTA; THE MAXIMUM DIAMETER AAA WAS 4.5CM. IMAGES FROM 2-YEARS POST-IMPLANT SHOWED THAT THE STENT GRAFT WAS IN THE APPROXIMATE SAME POSITION AS THE EARLIER STUDY. THE MAXIMUM DIAMETER TAA WAS APPROXIMATELY 10 CM, AND NO CONTRAST WAS SEEN WITHIN THE TAA. NO STENT GRAFT ISSUES WERE SEEN. THERE WAS ALSO NO OBVIOUS COMMUNICATION (FISTULA) OBSERVED BETWEEN THE ESOPHAGUS AND THE THORACIC AORTA OR STENT GRAFTS. THE CAUSE OF THE TAA EXPANSION AND HEMOPTYSIS COULD NOT BE DETERMINED FROM THESE IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125221 TALENT THORACIC THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00911521

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention