BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM WITH XCELERANT

    MDR report key: 1870848 · Received October 7, 2010

    Report

    Report Number
    2953200-2010-01902
    Event Type
    Death
    Date Received
    October 7, 2010
    Date of Event
    September 7, 2010
    Report Date
    January 3, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: ENDOLEAK. RESULTS/CONCLUSIONS: SEVERE ANGULATION OF THE THORACIC AORTA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S ANEURYSM IS RUPTURING AND IS BEING FLOW EMERGENTLY TO THE O.R. BY HELICOPTER. THE PHYSICIAN REQUESTED A 44 AND 46 TALENT THORACIC STENT GRAFT TO TREAT THE PATIENT WITH. THE PHYSICIAN THINKS THERE MIGHT BE SOME SORT OF ENDOLEAK LEADING TO THE ANEURYSM RUPTURE. IT WAS REPORTED THAT A STUDY WAS DONE AND THEY FOUND THE PROBLEMS WERE NOT RELATED TO THE ANEURYSM OR THE STENT GRAFTS. NO INTERVENTION WAS DONE AND THE PATIENT EXPIRED OF AN MI (HEART ATTACK).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM APPROXIMATELY 25 MONTHS AGO. IT WAS REPORTED 23 MONTHS POST STENT GRAFT IMPLANT THAT THE PATIENT DEVELOPED A PROXIMAL AND DISTAL PSEUDOANEURYSMS AND A PROXIMAL TYPE I ENDOLEAK, TREATED WITH A PROXIMAL MAIN AND A DISTAL ENDOLEAK AND PSEUDOANEURYSM WERE TREATED WITH TWO DISTAL DEVICES. (REF. MFR#2953200-2008-01116) THE DISTAL PSEUDOANEURYSM THAT WAS APPROXIMATELY 3 CM DISTALLY FROM THE MOST DISTAL STENT GRAFT WAS TREATED WITH TWO THORACIC STENT GRAFTS. IT WAS REPORTED TWO MONTHS LATER, THERE WAS A PROXIMAL DISSECTION POST SECONDARY INTERVENTION. (REF. MFR#2953200-2010-01574). NO FURTHER INFORMATION WAS PROVIDED AT THAT TIME IF THE DISSECTION WAS TREATED. THE PATIENT PRESENTED 30 DAYS POST SECONDARY INTERVENTION AND THE FOLLOW-UP CT DEMONSTRATED A TYPE III ENDOLEAK BETWEEN THE TWO DISTAL DEVICES (REF MFR # 2953200-2010-01902, AND MFR# 2953200-2010-01903). VESSEL MORPHOLOGY AT THIS TIME WAS REPORTED AS SEVERE ANGULATION OF THE THORACIC AORTA WHICH RESULTED IN THE TYPE III ENDOLEAK. THE PHYSICIAN TREATED THE TYPE III ENDOLEAK WITH A TALENT 42 PROXIMAL MAIN, BRIDGING THE TWO DEVICES AND THE ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM WITH XCELERANT MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00479377

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death| R