BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 3900309 · Received June 27, 2014

    Report

    Report Number
    2953200-2014-01298
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THREE VALIANT STENT GRAFTS WERE PLACED STARTING DISTALLY (BACK BUILT) 32X32XUNK MM, MIDDLE 38X34X150MM DISTAL TAPERED COMPONENT, AND MOST PROXIMALLY A 38X38XUNK MM PROXIMAL COMPONENT WHICH COVERED THE LEFT SUBCLAVIAN AND WENT PROXIMALLY TO ALMOST THE ORIGIN OF THE LEFT COMMON CAROTID ARTERY. THE LEFT SUBCLAVIAN HAD BEEN BYPASSED BUT NOT LIGATED OR COILED AT THE OSTIUM. THE PHYSICIAN STATED THAT A RECENT CT REVEALED A PROXIMAL TYPE I ENDOLEAK (ORIGINATING FROM THE LEFT SUBCLAVIAN (NOT APPARENT ON ANGIOGRAPHY) AS WELL AS A DISTAL TYPE I ENDOLEAK. THE PHYSICIAN INTENDED TO SNORKEL THE CELIAC ARTERY AND EXTEND THE GRAFT TO THE LEVEL OF THE SMA, HOWEVER THERE WAS AN UNKNOWN LESION IN THE PROXIMAL CELIAC ARTERY WHICH MADE PLACING A STENT THERE IMPOSSIBLE. AFTER APPROXIMATELY 90 MINUTES OF FLUOROSCOPIC TIME, THE DECISION WAS MADE TO COVER THE CELIAC WITHOUT THE SNORKEL AND EXTEND THE GRAFT AS PLANNED TO THE SMA. A 34X34X100MM VALIANT DISTAL COMPONENT WAS IMPLANTED WITHOUT DIFFICULTY. A RELIANT BALLOON WAS INSERTED AND ONLY THE OVERLAPPED AREA DILATED. THE DISTAL END TYPE I ENDOLEAK WAS DUE TO POTENTIALLY EXTENDING THE ORIGINAL DISSECTION FLAP. FINAL ANGIOGRAPHY REVEALED THE FALSE LUMEN CONTINUING TO FILL BUT NOT AS PREVALENT. THE PHYSICIAN PROPHYLACTICALLY IMPLANTED A STENT IN THE OSTIUM OF THE SMA TO INSURE ADEQUATE BLOOD FLOW, (THE STENT GRAFT WAS NOT COVERING THE SMA). SEVERAL COILS WERE PLACED AT THE OSTIUM OF THE LEFT SUBCLAVIAN ARTERY WHICH HAD NOT BEEN PLACED AT THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376829 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01691236

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention