BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 3971727 · Received July 31, 2014

    Report

    Report Number
    2953200-2014-01487
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, CONCLUSION: OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE (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 AORTIC DISSECTION IN ZONE 2. THE PHYSICIAN COVERED THE LSA AND PERFORMED A LCCA-LSA BYPASS PRIOR TO THE PROCEDURE AND THEN COILED THE LSA. THE DEVICES WERE IMPLANTED FROM ZONE 2 TO ZONE 3. THE INDEX PROCEDURE WAS SUCCESSFUL WITH NO ISSUES. IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH AN INFECTION AND A FEVER. THE DEVICE WAS CLEANSED DURING AN OPEN SURGERY FOR THE DESCENDING AORTA. SINCE THE INFECTION WAS CONFIRMED, THE INFECTED SITE OF THE DESCENDING AORTA WAS CLEANSED. IT WAS UNKNOWN WHETHER A SYNTHETIC VESSEL WAS IMPLANTED. A TEST FOR INFECTION WAS NOT CARRIED OUT AND THE EXACT INFECTIOUS ROUTE WAS NOT DETERMINED. THE RELEVANT DEVICE ITSELF WAS NOT INFECTED SO IT WAS NOT REMOVED. THE PATIENT WOULD NOT HAVE BECOME INFECTED WITH THE RELEVANT DEVICE, BUT WOULD HAVE BECOME INFECTED IN THE NATURAL ENVIRONMENT OF TICK-INFESTED AREA AS THE PATIENT WOULD HAVE GOTTEN INJURED DURING FISHING. TICKS CAN CAUSE A FEVER. THE PHYSICIAN STATED THAT THE RELEVANT DEVICE ITSELF HAD NO CAUSALITY WITH THE INFECTION. THE DEVICE REMAINS IN THE PATIENT¿S BODY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447865 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04251789

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention