BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 3024286 · Received March 27, 2013

    Report

    Report Number
    2953200-2013-00539
    Event Type
    Death
    Date Received
    March 27, 2013
    Date of Event
    August 1, 2013
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). FAILURE TO FOLLOW INSTRUCTIONS (INADEQUATE STENT GRAFT OVERLAP). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVE DISSECTION). USER ERROR CONTRIBUTED TO EVENT (INADEQUATE STENT GRAFT OVERLAP).

    Additional Manufacturer Narrative · 1

    EXACT DATE OF DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR ZONE 3 - ZONE 4, 59 MM DIAMETER X 150 MM LENGTH THORACIC AORTIC ANEURYSM 34 MONTHS AGO. THE PATIENT HAD A SYNTHETIC GRAFT IMPLANTED ON AN UNKNOWN DATE. THE PROXIMAL NECK WAS A 24MM IN DIAMETER WHICH WAS THE SYNTHETIC GRAFT AND THE DISTAL NECK WAS 37MM IN DIAMETER. VESSELS WERE NON-CALCIFIED AND NON-TORTUOUS. IT WAS REPORTED THAT THE ONE YEAR FOLLOW-UP REPORTED REVEALED THAT THE MAXIMUM ANEURYSM DIAMETER WAS 41 MM. THERE WAS A SEPARATION TYPE III ENDOLEAK BETWEEN TWO STENT GRAFTS. A CT SHOWED THE ENDOLEAK WAS BETWEEN THE TALENT (B)(4) AND THE TALENT (B)(4) WHICH WERE DEPLOYED AT THE DISTAL SIDE. ONE MONTH LATER ANOTHER MANUFACTURER'S WAS USED TO RESOLVE THE ENDOLEAK. IT WAS ALSO NOTED THAT THE CAUSE OF THE ENDOLEAK WAS DUE TO ONE OF THE PROXIMAL STENTS OF THE (B)(4) WHICH WAS NOT SEATED AND SLIGHTLY TURNED TO THE OUTSIDE. THE PHYSICIAN STATED THAT THE OVERLAP BETWEEN THE TWO STENT GRAFTS WAS NOT ADEQUATE AND CAUSED THE ENDOLEAK. NO FURTHER INFORMATION IS AVAILABLE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. PATIENT EXPIRED AND RELATIONSHIP TO PRODUCT AND PROCEDURE IS UNKNOWN. PER THE PHYSICIAN'S STATEMENT, NO ADDITIONAL INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126394 TALENT THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Death| R