BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 5495252 · Received March 11, 2016

    Report

    Report Number
    2953200-2016-00451
    Event Type
    Injury
    Date Received
    March 11, 2016
    Date of Event
    January 26, 2013
    Report Date
    February 17, 2016
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    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

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; FATE OF ANEURYSMAL COMMON ILIAC ARTERY LANDING ZONES USED FOR ENDOVASCULAR ANEURYSM REPAIR. CLAIRE L. GRIFFIN, MD , SALVATORE T. SCALI, MD , ROBERT J. FEEZOR, MD , CATHERINE K. CHANG, MD, KRISTINA A. GILES, MD, JAVAIRIAH FATIMA, MD, THOMAS S. HUBER, MD, PHD, AND ADAM W. BECK, MD. A TALENT AND ANEURX AAA STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF COMMON ILIAC ARTERY ANEURYSM. THE FOLLOWING INFORMATION IS REVIEWED IN THIS JOURNAL ARTICLE: NEUROLOGIC COMPLICATIONS WERE ALL SPINAL HEADACHES IN PATIENTS TREATED WITH AN EPIDURAL BLOOD PATCH; RENAL COMPLICATIONS WERE DOUBLING OF CREATININE LEVEL AND/OR 50% DECLINE IN ESTIMATED GLOMERULAR INFILTRATION RATE WHILE IN-HOSPITAL OR WITHIN 30 DAYS; ISCHEMIC COMPLICATIONS INCLUDED DISTAL EMBOLIZATION, LIMB OCCLUSION, ACCESS VESSEL STENOSIS, OR PELVIC ISCHEMIA. ABSTRACT PURPOSE: TO DETERMINE OUTCOMES OF ANEURYSMAL COMMON ILIAC ARTERIES (ACIA) USED FOR LANDING ZONES (LZS) DURING ENDOVASCULAR ANEURYSM REPAIR (EVAR). METHODS: THIS SINGLE-CENTER STUDY RETROSPECTIVELY COMPARED 57 EVAR PATIENTS (MEAN AGE 72±8 YEARS; 56 MEN) WITH 70 ACIAS (DIAMETER =20 MM) TO 25 CONTROL EVAR SUBJECTS (MEAN AGE 73±7 YEARS; 20 MEN) WITH 50 NORMAL (=15-MM) CIA LZS TREATED CONSECUTIVELY DURING THE SAME TIME INTERVAL. THE CIA LZ MEASUREMENTS WERE ANALYZED USING RANDOM EFFECTS LINEAR MIXED MODELS TO DETERMINE DIAMETER CHANGE OVER TIME. LIFE TABLES WERE USED TO ESTIMATE FREEDOM FROM ENDOLEAK, REINTERVENTION, AND ALL-CAUSE MORTALITY. RESULTS: THE MEAN MAXIMUM PREOPERATIVE CIA DIAMETER IN THE ACIA LZ GROUP WAS 24.8±4.5 MM (RANGE 20.0¿47.3, MEDIAN 23.9) VS 13.6±1.5 MM (RANGE 9.2¿15.0, MEDIAN 13.9).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151659 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention