BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2830342 · Received November 13, 2012

    Report

    Report Number
    2953200-2012-02177
    Event Type
    Death
    Date Received
    November 13, 2012
    Date of Event
    September 26, 2011
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH), - LACK OF INFORMATION (UNKNOWN CAUSE OF DEATH). CONCLUSION: LACK OF INFORMATION (UNKNOWN CAUSE OF DEATH).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. IT WAS REPORTED THAT 24 MONTHS POST INDEX PROCEDURE THERE WAS A DISTAL TYPE I ENDOLEAK. THE INVESTIGATOR INDICATED THAT THIS ENDOLEAK WAS CONTINUING FROM THE PREVIOUSLY REPORTED PERFUSION OF THE FALSE LUMEN. THE INVESTIGATOR INDICATED THAT THE PATIENT'S DEATH WAS REMOTELY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF AN ACUTE THORACIC AORTIC TYPE B DISSECTION. ANEURYSM AND VESSEL MORPHOLOGY WAS NOT REPORTED. MINIMAL TRUE LUMEN IS 3 MM, FALSE LUMEN IS 28 MM (EXTENDS TO THE ABDOMINAL AORTA - SUPRARENAL), THERE ARE THREE RE-ENTRY TEARS VISIBLE, THE FALSE LUMEN IS PARTIALLY THROMBOSED, THE NATIVE AORTA BETWEEN THE LSA AND LCC IS 31 MM IN DIAMETER, AT THE PROXIMAL NECK IT IS 31 MM, PROXIMAL TO THE DISSECTION 29 MM, DISSECTION DIAMETER 47 MM DISTAL TO THE DISSECTION 27 MM, RIGHT ACCESS VESSEL 9 MM, LEFT ACCESS VESSEL 9 MM, DISTAL NECK 27 MM. THE STENT GRAFT WAS IMPLANTED INTENTIONALLY COMPLETELY COVERING THE LSA, WITHOUT ISSUE. IT WAS REPORTED THAT ON FIVE DAYS POST IMPLANT, THERE IS CONTINUING PERFUSION OF THE FALSE LUMEN FROM THE PRE-EXISTING DISTAL ENTRY TEAR. NO INTERVENTION WAS PERFORMED. IT WAS REPORTED THAT 30 MONTHS POST INDEX PROCEDURE THE PATIENT EXPIRED SUDDENLY; THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00423476

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Death