BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 3759086 · Received April 18, 2014

    Report

    Report Number
    2953200-2014-00770
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    April 3, 2012
    Report Date
    March 27, 2014
    Manufacturer
    MEDTRONIC IRELAND,
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. CONTAINED RUPTURE OF A CELIAC ARTERY ANEURYSM TREATED WITH AORTIC ENDOGRAFT DEPLOYMENT AND ASSISTING PERCUTANEOUS COIL AND THROMBIN INFUSION. JOHN C PAPAKOSTAS, EMMANOUIL THEODOROPOULOS¿, GEORGE KARYDAS¿ AND PETROS K CHATZIGAKIS. VASCULAR, VOL. 21 NO. 3, PP. 183¿188, 2013 ON UNKNOWN DATES, AN UNKNOWN VALIANT (PLI-10) STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A CONTAINED RUPTURE OF THE CELIAC ARTERY. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DISTAL TYPE I ENDOLEAK, TYPE II ENDOLEAK, FEVER. THE PHYSICIAN ASSESSED THE CAUSE OF THE TYPE I B ENDOLEAK WAS ATTRIBUTED TO THE SHORT DISTAL LANDING ZONE AND/OR HIGH OVERSIZE OF THE GRAFT. THE DIAMETER OF THE LOWER THORACIC AORTA WAS 34 MM; THE AORTIC DIAMETER JUST ABOVE THE SMA WAS 28 MM AND THE AORTIC LENGTH BETWEEN CELIAC ARTERY AND SMA WAS 15 MM. THE AORTIC LENGTH 15 MM ABOVE THE CELIAC AXIS TO JUST ABOVE THE SMA WAS APPROXIMATELY 50 MM. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. IN THIS REPORT WE PRESENT A CASE OF A RUPTURED CELIAC ARTERY ANEURYSM (CAA) WITH A THROMBOSED DISTAL NECK, WHICH WAS TREATED AS AN EMERGENTLY WITH A DEPLOYMENT OF A TUBE THORACIC ENDOGRAFT TO THE DESCENDING THORACIC AND UPPER ABDOMINAL AORTA. THE INITIAL TREATMENT WAS ASSISTED WITH A SECOND STAGE PERCUTANEOUS, TRANSHEPATIC, ULTRASOUND GUIDED NEEDLE INFUSION OF COIL AND THROMBIN TO THE ANEURYSMAL SAC DUE TO TYPE IB ENDOLEAK, WITH IMMEDIATE THROMBOSIS OF THE ANEURYSM. THIS TECHNIQUE, ALTHOUGH NOT STANDARD, COULD ALSO BE CONSIDERED AS A USEFUL CHOICE FOR THE TREATMENT OF CAAS WITH WIDE PROXIMAL AND PATENT DISTAL NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237459 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND,

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention