BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 2890743 · Received December 31, 2012

    Report

    Report Number
    2953200-2012-02517
    Event Type
    Death
    Date Received
    December 31, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC IRELAND
    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 (ARTERIAL TRAUMA/DISSECTION/PERFORATION), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; PRE-EXISTING TYPE B DISSECTION AND CONNECTIVE TISSUE DISORDER), UNAPPROVED USE OF DEVICE (TREATMENT OF A TYPE B DISSECTION). CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; PRE-EXISTING TYPE B DISSECTION AND CONNECTIVE TISSUE DISORDER), OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (TREATMENT OF A TYPE B DISSECTION).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED EMERGENTLY IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A TYPE B DISSECTION. THERE WAS A STEEP ARCH. PROXIMAL AORTA WAS 22 MM IN DIAMETER. IT WAS REPORTED THAT WHILE DELIVERING THE PROXIMAL MAIN STENT GRAFT THE ARCHER WIRE WAS GOING AROUND THE AORTIC ARCH WHEN THE WIRE FOLDED INTO THE INNOMINATE (WHEN THE DELIVERY SYSTEM WAS PASSED OVER THE ARCH) CAUSING A DISSECTION OF THE INNOMINATE ARTERY. THE PHYSICIAN PROCEEDED TO DEPLOY THE PROXIMAL MAIN UNINTENTIONALLY COVERING THE LEFT CAROTID ARTERY. THE SECOND STENT GRAFT WAS DEPLOYED WHEN IT WAS NOTED THAT THERE WAS A TYPE A DISSECTION IN THE ASCENDING AORTA. THE PHYSICIAN OPENED THE PATIENT AND ATTEMPTED TO REPAIR THE ASCENDING AORTA AND LEFT CAROTID ARTERY. HOWEVER, IT WAS NOTED THAT THE DISSECTION EXTENDED OUT TO THE CORONARY ARTERIES AND THE VENTRICLES. THE SURGERY LASTED FOR MANY HOURS INTO THE NIGHT. HOWEVER, THE PATIENT EXPIRED. THE PHYSICIAN BELIEVES THAT THE PATIENT HAD AN UNDIAGNOSED CONNECTIVE TISSUE DISORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01069231

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Death