BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2191227 · Received July 29, 2011

    Report

    Report Number
    2953200-2011-01360
    Event Type
    Death
    Date Received
    July 29, 2011
    Date of Event
    July 9, 2011
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ENDOLEAK). RESULTS AND CONCLUSION: (TORTUOUS THORACIC AORTA).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM, APPROX ONE YEAR AND 9 MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED AS A TORTUOUS THORACIC AORTA. IT WAS REPORTED THAT DURING A RECENT ROUTINE FOLLOW-UP, A DISTAL JUNCTIONAL TYPE 3 ENDOLEAK WAS SEEN BETWEEN TWO OF THE DISTAL MAIN STENT GRAFTS WITH THE THORACIC ANEURYSM ENLARGING TO 8.1 CM DIAMETER (REF MFR # 2953200-2011-01360, 2953200-2011-01361 AND 2953200-2011-01362). IT WAS ALSO NOTED THAT, AT THE TIME OF IMPLANT, THE LEFT SUBCLAVIAN ARTERY WAS COVERED BY THE PROXIMAL MOST STENT GRAFT. THE ARTERY WAS NOT COILED AND THERE IS A TYPE 2 ENDOLEAK COMING FROM THE LEFT SUBCLAVIAN ARTERY AND FILLING THE ANEURYSM SAC. ON ANGIOGRAM, IT WAS DIFFICULT TO VISUALIZE THE JUNCTIONAL TYPE 3 ENDOLEAK. THE PHYSICIAN DECIDED TO RELINE THE JUNCTIONS BETWEEN THE 3 DISTAL MOST STENT GRAFTS WITH A 46X46X197 TALENT CAPTIVIA STENT GRAFT AND COIL THE LEFT SUBCLAVIAN ARTERY. THESE INTERVENTIONS RESOLVED THE ENDOLEAKS. THE CAUSE OF THE TYPE III ENDOLEAK IS UNK. THE TYPE 2 ENDOLEAK WAS ANATOMY RELATED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FOR THIS CASE HAS BEEN RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD A RETROPERITONEAL BLEED AND A MI. THE INVESTIGATOR STATED THAT THE RELATIONSHIP OF THE STENT GRAFT IS UNKNOWN AND NOT RELATED TO THE PROCEDURE. THE PATIENT WAS TREATED WITH BLOOD TRANSFUSION FOR THE RETROPERITONEAL BLEED AND MEDICATION FOR THE MI RESOLVING. IT WAS REPORTED THAT THE PATIENT HAD A PSEUDOANEURYSM THAT WAS NOTED. IT WAS REPORTED THAT THE PATIENT LATER EXPIRED DUE TO A THORACIC ANEURYSM, THERE WAS NO AUTOPSY PERFORMED, THE PATIENT REFUSED TO HAVE ANY FURTHER INTERVENTION AND EXPIRED AT HOME UNDER HOSPICE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00219915

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| R