BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4243939 · Received November 11, 2014

    Report

    Report Number
    2953200-2014-02380
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    July 3, 2014
    Report Date
    December 3, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT WAS IMPLANTED FOR TREATMENT OF A CHRONIC 52 MM THORACIC AORTIC DISSECTION, TYPE B. THE PROXIMAL AORTIC NECK WAS 28 MM IN DIAMETER AND 30 MM IN LENGTH. THE DISTAL AORTIC NECK 37 MM IN DIAMETER AND 50 MM IN LENGTH. THE LSA WAS INTENTIONALLY COVERED. IT WAS REPORTED THAT THE PATIENT HAD A CT WITH CONTRAST NOTING A TYPE II ENDOLEAK. FALSE LUMEN PERFUSION, EVENT IS CONTINUING, RE-ENTRY THROUGH LEFT CAROTID. THE EVENT WAS ALSO NOTED WITH A CT WITH CONTRAST THREE MONTHS LATER.

    Description of Event or Problem · 1

    A REVIEW OF RETURNED CTA¿S FROM 3 DAYS POST-IMPLANT REVEALED THAT A VALIANT WAS IMPLANTED COVERING THE LSA, EXTENDING DISTALLY INTO THE DESCENDING THORACIC AORTA. THE BARE SPRING IS NEAR THE LEVEL OF THE LCCA. THE MAX DIAMETER TAA IS APPROXIMATELY 4.5CM. THERE IS CONTRAST SEEN WITHIN THE PROXIMAL SAC. THE LSA AND LCCA ARE BOTH BEING PERFUSED. THERE IS A STENT PLACED INTO THE LCCA AND RCCA, AND A POSSIBLE DISSECTION AT THE LCCA AND BRACHIOCEPHALIC ORIGIN. THE PROXIMAL STENT GRAFT OD IS 21MM AND THE DISTAL STENT GRAFT OD IS 20MM. THE DISSECTION EXTENDS DISTAL TO THE STENT GRAFT INTO THE LEFT ILIAC ARTERY, AND A STENT IS SEEN PLACED INTO THE LEFT EXTERNAL ILIAC ARTERY. NO STENT GRAFT ISSUES ARE OBSERVED. A REVIEW OF CTA¿S FROM 3-MONTHS POST-IMPLANT SHOWED SIMILAR FINDINGS FROM THE EARLIER POST 3 DAY CT¿S. NO STENT GRAFT ISSUES ARE OBSERVED. THE CAUSE OF THE FALSE LUMEN PERFUSION IS UNKNOWN. MAY BE PATIENT RELATED FROM THE PRE-IMPLANT DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725544 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04201221

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR