BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2230391 · Received August 15, 2011

    Report

    Report Number
    2953200-2011-01444
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ENDOLEAK, CONVERSION TO OPEN REPAIR. UNKNOWN CAUSE OF ENDOLEAK; PENDING DEVICE EVALUATION. EVALUATION, CONCLUSIONS: UNKNOWN CAUSE OF ENDOLEAK; PENDING DEVICE EVALUATION.

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE URGENT ENDOVASCULAR TREATMENT OF A 6 CM IN DIAMETER X 2.3 CM LONG THORACIC AORTIC ANEURYSM APPROXIMATELY 5 WEEKS AGO. VESSELS WERE NON-TORTUOUS AND NON-CALCIFIED. THE NATIVE AORTIC DIAMETER WAS 30 MM PROXIMALLY AND 28 MM DISTALLY. IT WAS REPORTED THAT AFTER A PROXIMAL 34X30X150 VALIANT STENT GRAFT (MFR REPORT # 3953200-2011-01443) AND A DISTAL 36X32X150 VALIANT STENT GRAFT (MFR REPORT # 2953200-2011-01444) WERE IMPLANTED, A PROXIMAL TYPE I ENDOLEAK WAS EVIDENT. THE PHYSICIAN ELECTED TO INTERVENE BY PACING A 34X34X150 VALIANT STENT GRAFT (MFR REPORT # 2953200-2011-01445) INSIDE THE PROXIMAL STENT GRAFT TO INCREASE RADIAL FORCE; THE FINAL ANGIOGRAPHY SHOWED NO ENDOLEAK. THEN, 1 WEEK POST-IMPLANTATION, THE FOLLOW-UP IMAGING SHOWED AN UNKNOWN ENDOLEAK AND ANEURYSM SAC ENLARGEMENT. THE PHYSICIAN ELECTED TO CONVERT THE PATIENT TO AN OPEN SURGICAL REPAIR. WHEN THE ANEURYSM WAS OPENED, BLOOD WAS SEEN LEAKING FROM THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS STABLE. THE EXPLANTED STENT GRAFTS HAVE BEEN RECEIVED BY MEDTRONIC, AND THE ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00488837

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention