BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2000363 · Received February 18, 2011

    Report

    Report Number
    2953200-2011-00461
    Event Type
    Injury
    Date Received
    February 18, 2011
    Report Date
    January 21, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (LOT NUMBER, IMPLANT AND EXPLANT DATE WERE NOT PROVIDED), (ENDOLEAK, MIGRATION). CONCLUSION: (LOT NUMBER, IMPLANT AND EXPLANT DATE WERE NOT PROVIDED). INFLUENCE OF DIFFERENT SELF-EXPANDING STENT-GRAFT TYPES ON REMODELING OF THE AORTIC NECK AFTER ENDOVASCULAR ANEURYSM REPAIR. (J ENDOVASC. THER. 2010;17:677-684.) NONE OF THE EVENTS IN THE ARTICLE MATCH EVENT INFO ALREADY KNOWN TO MEDTRONIC. THE PHYSICIAN WAS CONTACTED AND REQUESTED TO PROVIDE SPECIFIC INFO RELATED TO EACH EVENT RELATED TO ANEURX DEVICES, SUCH AS THE LOT NUMBER, IMPLANT DATE, AND EXPLANT DATE. NO REPLY HAS BEEN RECEIVED FROM THE PHYSICIAN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: INFLUENCE OF DIFFERENT SELF-EXPANDING STENT-GRAFT TYPES ON REMODELING OF THE AORTIC NECK AFTER ENDOVASCULAR ANEURYSM REPAIR. (J ENDOVASC. THER. 2010;17:677-684.) PURPOSE: TO EVALUATE AORTIC NECK CHANGES, SPECIFICALLY AORTIC NECK DILATATION, OVER A 10-YEAR PERIOD IN PATIENTS UNDERGOING ENDOVASCULAR ANEURYSM REPAIR (EVAR) FOR ABDOMINAL AORTIC ANEURYSM. METHODS: ALL PATIENTS WHO UNDERWENT ELECTIVE EVAR FROM 1998 THROUGH 2007 WERE ANALYZED RETROSPECTIVELY. AMONG THESE, 103 PATIENTS (96 MEN, MEAN AGE (B)(6) YEARS, RANGE (B)(6)) WHO RECEIVED THE 3 MOST FREQUENTLY IMPLANTED SELF-EXPANDING STENT GRAFTS (35 TALENT, 39 EXCLUDER, AND 29 ZENITH) AND HAD A MINIMUM 3-MONTH IMAGING F/U AT OUR DEPT WERE SELECTED FOR THIS STUDY. ALL DIAMETERS WERE MEASURED PERPENDICULAR TO THE CENTERLINE OF FLOW ON COMPUTED TOMOGRAPHY; BASELINE DATA WERE DERIVED FROM THE FIRST POSTOPERATIVE SCAN. STENT-GRAFT MIGRATION WAS MEASURED FROM THE LOWERMOST RENAL ARTERY TO THE FIRST STRUT OF THE STENT-GRAFT. THE AVERAGE AAA SIZE WAS 53.8 MM FOR TALENT PATIENTS. INFRARENAL AORTIC NECK DIAMETERS WERE 29.1 +/- 3.7 MM FOR TALENT PATIENTS. RESULTS: DURING A MEAN F/U OF 39.4 MONTHS (RANGE 3-108.8), INFRARENAL AORTIC NECK DILATATION (>2 MM) WAS FOUND IN 10 PATIENTS (28.6) IN THE TALENT GROUP. STENT-GRAFT MIGRATION >2 MM WAS SEEN IN 2 (1.9%) OF THE TALENT PATIENTS. THE OVERALL ENDOLEAK RATES WERE 37.1% FOR TALENT, WHICH INCLUDED 4 EARLY PROXIMAL TYPE I LEAKS AND 1 LATE PROXIMAL TYPE I LEAK AND 9 TYPE II ENDOLEAKS. ONE TALENT PT WAS CONVERTED TO OPEN REPAIR BECAUSE OF STENT-GRAFT MIGRATION. CONCLUSION: ONLY A SMALL NUMBER OF THE PATIENTS TREATED WITH SELF-EXPANDING STENT-GRAFTS SHOW NOTABLE INFRARENAL AORTIC NECK DILATATION, WHICH DOES NOT APPEAR TO BE RELATED TO THE STENT-GRAFT MODEL. ALMOST ALL CASES OF AORTIC NECK DILATATION EXCEEDED THE PERCENTAGE OF OVERSIZING; LESS THAN A THIRD OF PATIENTS WITH AORTIC NECK DILATATION REQUIRED THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention