BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4596806 · Received March 12, 2015

    Report

    Report Number
    2953200-2015-00504
    Event Type
    Injury
    Date Received
    March 12, 2015
    Date of Event
    February 21, 2015
    Report Date
    February 21, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 6.2 CM DIAMETER THORACIC AORTIC ANEURYSM. THE PROXIMAL LANDING ZONE (PLZ) DISTAL TO LEFT COMMON CAROTID ARTERY MEASURED 36.9 MM IN DIAMETER. THE PLZ DISTAL TO THE LEFT SUBCLAVIAN ARTERY MEASURED 31 MM IN DIAMETER. THE PLZ PROXIMAL TO THORACIC AORTIC ANEURYSM MEASURED 31.8 MM IN DIAMETER. THE PLZ MEASURED 28.5 MM IN LENGTH. THE DISTAL LANDING ZONE (DLZ) MEASURED 41.0 TO 42.0 MM IN DIAMETER WITH THROMBUS. THE DLZ PROXIMAL TO CELIAC MEASURED 36.1 MM IN DIAMETER. THE RIGHT COMMON ILIAC ARTERY MEASURED 10.2 MM IN DIAMETER. THE LEFT COMMON ILIAC ARTERY MEASURED 9.3 MM IN DIAMETER. THE DESCENDING THORACIC AORTA WAS TORTUOUS. THE EXTERNAL ILIAC ARTERIES MEASURED 7 MM IN DIAMETER BILATERALLY WITHOUT PLAQUE. IT WAS REPORTED THAT PATIENT PRESENTED TO THE EMERGENCY ROOM WITH BACK PAIN. THERE WAS A JUNCTIONAL COMPONENT TYPE III ENDOLEAK BETWEEN THE TWO VALIANT STENT GRAFTS. THERE WAS AT LEAST 5 CM OF OVERLAP BETWEEN THE TWO STENT GRAFTS. PER THE PHYSICIAN, THE TYPE III ENDOLEAK WAS CAUSED BY THE ANGLE OF THE DESCENDING THORACIC AORTA PROXIMAL TO THE CELIAC ARTERY. THERE WAS ALSO A TYPE I ENDOLEAK WHICH WAS BALLOONED OUT WITH RELIANT BALLOON. THE REALIGNING OF THE STENT GRAFT WAS DONE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. FILM REVIEW AND ANALYSIS: REVIEW OF PRE-IMPLANT CTA¿S CONFIRMED THAT THE THORACIC AORTA WAS SEVERELY TORTUOUS. THE MAXIMUM DIAMETER TAA WAS APPROXIMATELY 6CM. THE ARCH WAS ACUTELY ANGULATED 90DEG, WITH AREAS OF VISIBLE CALCIFICATION. THE DESCENDING THORACIC ALSO CONTAINED LARGE AMOUNTS OF IRREGULAR THROMBUS. THE ABDOMINAL AORTIC PROXIMAL NECK WAS NOTED TO BE SEVERELY ANGULATED AND CALCIFIED. THE ILIACS WERE CALCIFIED AND NON-TORTUOUS. REVIEW OF CTA¿S FROM 9 DAYS POST-IMPLANT REVEALED THAT MULTIPLE VALIANT¿S HAD BEEN IMPLANTED FROM JUST DISTAL TO THE LSA, EXTENDING OVER THE ANGULATED ARCH AND ACROSS THE TORTUOUS DESCENDING THORACIC COVERING TO JUST PROXIMAL TO THE CELIAC ARTERY. THE MAX DIAMETER TAA IS APPROXIMATELY 6CM. THE PROXIMAL STENT GRAFT OD IS 30MM AND THERE IS A POSSIBLE PROXIMAL TYPE I ENDOLEAK SEEN. WITHIN THE TORTUOUS SEGMENT OF THE THORACIC DESCENDING THORACIC THERE IS A PROBABLE TYPE III JUNCTIONAL ENDOLEAK BETWEEN THE MIDDLE AND MOST DISTALLY IMPLANTED DEVICES. THE FLOW LUMEN DIAMETER NEAR THIS LIKELY DISCONNECTION MEASURED 39MM. THE DISTAL STENT GRAFT OD NEAR THE CELIAC IS 41X45M. THE STENT GRAFT IS PATENT. THE EXACT CAUSE OF THE PROXIMAL TYPE I ENDOLEAK RESOLVED BY BALLOONING IS UNCERTAIN. THE CAUSE OF THE JUNCTIONAL TYPE III ENDOLEAK IS ALSO UNKNOWN. THE AMOUNT OF OVERLAP AT IMPLANT IS UNKNOWN. IT IS POSSIBLE THAT THE SEVERELY TORTUOUS ANATOMY MAY HAVE CONTRIBUTED. LACK OF COMPONENT OVERSIZING ACROSS THIS JUNCTION MAY HAVE ALSO CONTRIBUTED TO THE SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171854 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V06002335

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention