BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT STENT GRAFT SYSTEM

    MDR report key: 2834306 · Received November 15, 2012

    Report

    Report Number
    2953200-2012-02209
    Event Type
    Death
    Date Received
    November 15, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: (FILMS). RESULTS: INHERENT RISK OF PROCEDURE (DEATH). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVE DISSECTION). INCORRECT TECHNIQUE/PROCEDURE (TREATING A PRE-EXISTING CONDITION; PRE-OPERATIVE DISSECTION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVE DISSECTION). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (TREATING A PRE-EXISTING CONDITION; PRE-OPERATIVE DISSECTION).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTA DISSECTION. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. THE PATIENT WAS TREATED CONSERVATIVELY AT THE INDEX PROCEDURE. IT WAS REPORTED THAT ONE MONTH LATER THE PATIENT RETURNED DUE TO A TYPE I ENDOLEAK AND THE INITIAL THORACIC DISSECTION WAS NOT COMPLETELY COVERED. TWO ADDITIONAL VALIANT STENT GRAFTS WERE SUCCESSFULLY IMPLANTED TO TREAT THE PRE-OPERATIVE DISSECTION. IT WAS REPORTED ONE DAY POST-SECONDARY INTERVENTION THE PATIENT WAS FINE AND SUDDENLY THE PATIENT EXPIRED. THERE WERE NO SIGNS OF ANY ISSUES PRIOR TO THE PATIENT'S DEATH, THE PATIENT'S BLOOD PRESSURE DID NOT DROP. NO AUTOPSY WAS DONE. THE REVIEW OF RETURNED ANGIOGRAM IMAGES AT THE TIME OF IMPLANTATION SHOWED THAT THE STENT GRAFT WAS IMPLANTED JUST DISTAL TO THE LSA. NO OBVIOUS STENT GRAFT ISSUES WERE OBSERVED. POST-IMPLANT CTA SHOWED THAT THE DISSECTION IS NOT EXCLUDED BY THE STENT GRAFT. THE DISSECTION EXTENDS FROM THE PROXIMAL STENT GRAFT MARGIN, DISTALLY TO THE ABDOMINAL AORTIC BIFURCATION. THERE IS ALSO A POSSIBLE PROXIMAL TYPE I ENDOLEAK. THE THORACIC AORTA DIAMETER PROXIMAL TO THE INNOMINATE ARTERY IS 41X48MM. THE CAUSE OF THE EVENTS COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF4646C100TU V01144781

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Death