BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM - COILTRAC

    MDR report key: 1667418 · Received April 23, 2010

    Report

    Report Number
    2953200-2010-00715
    Event Type
    Death
    Date Received
    April 23, 2010
    Date of Event
    March 25, 2010
    Report Date
    November 6, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): RESULTS: DEATH, CEREBROVASCULAR ACCIDENT. MODERATE THROMBUS/ATHEROMA/PLAQUE SURROUNDING THE ANEURYSM.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT DEVICE WAS IMPLANTED INTO A PATIENT FOR THE TREATMENT OF A 46 MM IN DIAMETER X 70 MM LONG SACCULAR THORACIC AORTIC ANEURYSM AT ZONE 2. THE PROXIMAL AORTIC NECK WAS 36 MM IN DIAMETER, AND THE DISTAL AORTIC NECK WAS 29 MM IN DIAMETER. THERE WAS A MODERATE AMOUNT OF THROMBUS/ATHEROMA/PLAQUE SURROUNDING THE ANEURYSM. IT WAS REPORTED THAT TWO TALENT THORACIC STENT GRAFTS (MFR REPORT # 2953200-2010-00716) WERE IMPLANTED TO EXCLUDE THE ANEURYSM WITHOUT ANY ISSUES. AFTER RECOVERY FROM ANESTHESIA, IT WAS NOTED THAT THE PATIENT HAD A CEREBRAL INFARCTION. MORE SPECIFICALLY, PER A FOLLOW-UP MRI ACQUIRED ONE DAY POST-IMPLANTATION, A CEREBELLAR INFARCTION WAS DIAGNOSED. THE PHYSICIAN COMMENTED THAT THERE WAS A POSSIBILITY THAT SOME THROMBUS, ATHEROMA, AND/OR PLAQUE MIGHT HAVE MOVED TO THE LEFT VERTEBRAL ARTERY THROUGH THE LEFT SUBCLAVIAN ARTERY, RESULTING IN THE CEREBELLAR INFARCTION. IT WAS THEN REPORTED THAT THE PATIENT EXPIRED ON AN UNKNOWN DATE FROM EXPANSION OF THE CEREBRAL INFARCTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. IT WAS REPORTED THAT THE INVESTIGATOR ASSESSED THE CEREBRAL INFARCTION AS RELATED TO THE PROCEDURE AND REQUIRED IMPLANT OF AN ADDITIONAL STENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM - COILTRAC MIH MEDTRONIC CARDIOVASCULAR NA V00322254

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| R