BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT SYSTEM

    MDR report key: 2840838 · Received November 20, 2012

    Report

    Report Number
    2953200-2012-02250
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    March 21, 2010
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (VESSEL OCCLUSION).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. IT WAS REPORTED THAT THE PATIENT HAD PAIN AND SWELLING TO THE RIGHT LOWER EXTREMITY FOR ONE WEEK. THE INVESTIGATOR INDICATED THAT THE EVENT WAS NO RELATED TO THE PROCEDURE BUT IT IS UNKNOWN IF THE EVENT IS RELATED TO THE DEVICE. THERE HAS BEEN NO FURTHER TREATMENT FOR THIS EVENT. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    A VALIANT THORACIC STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 4.2 CM DIAMETER THORACIC AORTIC ANEURYSM IN ZONE 2 APPROXIMATELY 56 MONTHS AGO. THE PROXIMAL AORTA WAS 24 MM IN DIAMETER AND 32 MM IN LENGTH. DISTAL AORTA WAS 21 MM IN DIAMETER. THE RIGHT FEMORAL ARTERY WAS 10 MM IN DIAMETER. THE ACCESS ARTERIES WERE MILDLY TORTUOUS. THE VALIANT (B)(4) STENT GRAFT WAS IMPLANTED FROM THE LEFT SIDE, INTENTIONALLY COVERING THE LEFT SUBCLAVIAN ARTERY. ONE MONTH POST IMPLANT THE PATIENT PRESENTED WITH LEFT ARM WEAKNESS ASSOCIATED WITH DIZZINESS DUE TO THE LEFT SUBCLAVIAN ARTERY BEING COVERED BY THE VALIANT STENT GRAFT. THE PATIENT RECOVERED WITHOUT TREATMENT AT THE TIME OF THE ONE YEAR FOLLOW-UP. THE INVESTIGATOR ASSESSED THIS EVENT TO BE UNRELATED TO THE STUDY DEVICE AND STUDY PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. PLEASE NOTE THAT THIS MODEL NUMBER (B)(4) IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE (B)(4) WHICH IS APPROVED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00000814

    Patients

    Seq Age Sex Outcome Treatment
    1