BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 3186326 · Received June 24, 2013

    Report

    Report Number
    2953200-2013-01185
    Event Type
    Injury
    Date Received
    June 24, 2013
    Date of Event
    January 24, 2013
    Report Date
    May 27, 2013
    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) RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); LACK OF INFORMATION, CAUSE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR 53 MM IN DIAMETER AND 20 MM IN LENGTH THORACIC AORTIC ANEURYSM. THE PROXIMAL NECK WAS 29 MM IN DIAMETER. THE COMMON ILIAC ARTERY WAS MILDLY CALCIFIED. A CT SHOWED THE ANEURYSM AT 60 MM IN DIAMETER DUE TO A TYPE IA ENDOLEAK. A YEAR LATER THE CT SHOWED THE ANEURYSM AT 68 MM IN DIAMETER AND IT WAS CONFIRMED THAT THE ENDOLEAK WAS RESIDUAL. THE FOLLOWING YEAR THE ANEURYSM DIAMETER HAD EXPANDED, THE PATIENT WAS TREATED WITH A VALIANT STENT GRAFT ON THE PROXIMAL SIDE OF THE 3232, HOWEVER, THE ENDOLEAK DID NOT RESOLVE. THEREFORE, ANOTHER VALIANT STENT GRAFT WAS IMPLANTED ON THE PROXIMAL SIDE OF 3232200. WHEN THE DEVICES WERE IMPLANTED, A CHIMNEY TECHNIQUE WAS ALSO PERFORMED TO SAVE THE LEFT COMMON CAROTID ARTERY. THE ENDOLEAK RESOLVED AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN ASSESSED RELATIONSHIP TO THE DEVICE IS UNKNOWN AND NOT RELATED TO THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286552 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention