BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 3036574 · Received April 4, 2013

    Report

    Report Number
    2953200-2013-00624
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK. LACK OF INFORMATION (UNKNOWN CAUSE OF ENDOLEAK). CONCLUSION: LACK OF INFORMATION (UNKNOWN CAUSE OF ENDOLEAK).

    Description of Event or Problem · 1

    A VALIANT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PSEUDO-ANEURYSM OF THE DESCENDING THORACIC AORTA APPROXIMATELY THREE WEEKS AGO. THE ANEURYSM WAS APPROXIMATELY 3 CM DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE VESSELS WERE NON-TORTUOUS AND 9-10MM IN DIAMETER. IT WAS REPORTED THAT UPON COMPLETION OF THE INDEX PROCEDURE WITH BALLOONING AN ANGIOGRAM SHOWED THAT THERE APPEARED TO BE A PROXIMAL TYPE I ENDOLEAK THAT WAS THOUGHT MAY RESOLVE WITHIN THE NEXT 24 HOURS. POST OPERATIVELY A CAT SCAN SHOWED THERE WAS STILL AN ENDOLEAK. REVIEW OF THE CAT SCAN REVEALED THAT THE ENDOLEAK WAS A TYPE III FABRIC ENDOLEAK. THE CAUSE OF THE ENDOLEAK IS UNKNOWN. THE DAYS LATER A VALIANT 3232100 WAS IMPLANTED WITHIN THE FIRST STENT GRAFT AND THE ENDOLEAK SUCCESSFULLY RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139300 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01103114

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention