BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA STENT GRAFT SYSTEM

    MDR report key: 2840835 · Received November 20, 2012

    Report

    Report Number
    2953200-2012-02249
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: 205 FAILURE TO FOLLOW INSTRUCTIONS (CLOSED WEB DEVICE USED AS THE PROXIMAL STENT GRAFT); INHERENT RISK OF PROCEDURE (STENT GRAFT KINK / INACCURATE DELIVERY). CONCLUSIONS: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (CLOSED WEB DEVICE USED AS THE PROXIMAL STENT GRAFT).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 4.5 CM DIAMETER THORACIC AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. THE VESSELS WERE NON-TORTUOUS AND THERE WAS SLIGHT VESSEL CALCIFICATION. IT WAS REPORTED THAT DURING DEPLOYMENT OF THE VALIANT CAPTIVIA (B)(4), AFTER THE INITIAL TWO STENT RINGS WERE DEPLOYED, THE STENT GRAFT MIGRATED DISTALLY TOWARDS ITSELF. THE STENT GRAFT WAS KINKED TOWARDS ONE SIDE AND AFTER DEPLOYMENT THE STENT GRAFT LANDED AT TOP OF THE ANEURYSM. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER VALIANT CAPTIVIA, A (B)(4) WHICH RESOLVED THE MIGRATION. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FREE FLOW CONFIGURATION STENT GRAFT WAS NOT USED AS THE PHYSICIAN BELIEVED IT MIGHT CREATE A DISSECTION FOR THIS PARTICULAR CASE. THE PATIENT'S BLOOD PRESSURE WAS LOWERED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT CAPTIVIA STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00952033

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention