BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 6595231 · Received May 26, 2017

    Report

    Report Number
    2953200-2017-00883
    Event Type
    Injury
    Date Received
    May 26, 2017
    Date of Event
    August 24, 2010
    Report Date
    May 4, 2017
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; CLINICAL OUTCOMES FOR HOSTILE VERSUS FAVORABLE AORTIC NECK ANATOMY IN ENDOVASCULAR AORTIC ANEURYSM REPAIR USING MODULAR DEVICES ALI F. ABURAHM, MD, JOHN E. CAMPBELL, MD, ALBEIR Y. MOUSA, MD, STEPHEN M. HASS, MD, PATRICK A. STONE, MD, AKHILESH JAIN, MD, ARAVINDA NANJUNDAPPA, MD, L. SCOTT DEAN, PHD, MBA, TAMMI KEIFFER, RN, AND JOSEPH HABIB, MD. ( J VASC SURG 2011;54:13-21.) DOI:10.1016/J.JVS.2010.12.010 ANEURX AND TALENT AAA STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS FOR ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. THE FOLLOWING INFORMATION IS IN THIS JOURNAL ARTICLE: OCCLUSION, PROXIMAL TYPE I ENDOLEAK, DISTAL TYPE I ENDOLEAK, TYPE III ENDOLEAK, TYPE IV ENDOLEAK, STENT GRAFT MIGRATION, MYOCARDIAL INFARCTION, PERIPHERAL EMBOLIZATION, HEMATOMA/BLEEDING, WOUND INFECTION, SEPSIS, COLON ISCHEMIA, STENT GRAFT PATENCY, AORTIC SAC EXPANSION, CONVERSION TO OPEN REPAIR, ANEURYSM RUPTURE, ACUTE RENAL FAILURE, PARALYSIS, AND ANEURYSM-RELATED MORTALITY/PERIOPERATIVE DEATH. ABSTRACT BACKGROUND: ENDOVASCULAR ANEURYSM REPAIR (EVAR) IS NOT GENERALLY RECOMMENDED FOR PATIENTS WITH HOSTILE NECK ANATOMY. THIS STUDY ANALYZED THE CLINICAL IMPLICATIONS OF VARIOUS CLINICAL FEATURES OF PROXIMAL AORTIC NECK ANATOMY. METHODS: PROSPECTIVELY COLLECTED DATA FROM 258 EVAR PATIENTS USING MODULAR DEVICES WERE ANALYZED. PATIENTS WERE CLASSIFIED AS HAVING FAVORABLE NECK ANATOMY (FNA) OR HOSTILE NECK ANATOMY (HNA). HNA WAS DEFINED AS ANY OR ALL OF LENGTH OF 60°, DIAMETER OF >28 MM, >50% CIRCUMFERENTIAL THROMBUS, >50% CALCIFIED NECK, AND REVERSE TAPER. UNIVARIATE, MULTIVARIATE, AND KAPLAN-MEIER ANALYSES WERE USED TO COMPARE EARLY AND LATE CLINICAL OUTCOMES. RESULTS: FNA WAS PRESENT IN 37% AND HNA WAS PRESENT IN 63%. CLINICAL AND DEMOGRAPHIC CHARACTERISTICS WERE COMPARABLE. TECHNICAL SUCCESS WAS 99%. MEAN FOLLOW-UP WAS 22 MONTHS (RANGE, 1-78 MONTHS). PERIOPERATIVE COMPLICATION RATES WERE 3% FOR FNA VS 16% FOR HNA (P .0027). PERIOPERATIVE DEATHS WERE 0% FOR FNA AND 3% FOR HNA (P = .2997). PROXIMAL TYPE I EARLY ENDOLEAKS (INTRAOPERATIVE) OCCURRED IN 9% OF FNA VS 22% FOR HNA (P =.0202). INTRAOPERATIVE PROXIMAL AORTIC CUFFS WERE USED TO SEAL ENDOLEAKS IN 9% OF FNA VS 22% OF HNA (P = .0093). AT LATE FOLLOW-UP, ABDOMINAL AORTIC ANEURYSM EXPANSION WAS NOTED IN 6% OFFNA VS 7% OF HNA (P = .8509). RATES OF FREEDOM FROM LATE TYPE I ENDOLEAKS AT 1, 2, 3, AND 4 YEARS WERE 97%, 97%, 97%, AND 90% FOR FNA VS 89%, 89%, 89%, AND 89% FOR HNA (P = .1224); RATES FOR LATE INTERVENTIONS WERE 95%, 90%, 90%, AND 90% FOR FNA VS 95%, 93%, 91%, AND 85% FOR HNA (P = .6902). GRAFT PATENCY AT 1, 2, AND 3 YEARS WAS 99%, 99%, AND 99% FOR FNA VS 97%, 92%, AND 90% FOR HNA (P = .0925). THE SURVIVAL RATES WERE 93%, 84%, 76%, AND 76% FOR FNA VS 88%, 82%, 74%, AND 66% FOR HNA (P = .2631). REVERSE TAPER WAS A SIGNIFICANT PREDICTOR FOR EARLY TYPE I ENDOLEAK (ODDS RATIO [OR], 5.25, P <(><<)> .0001), REVERSE TAPER (OR, 5.95; P <(><<)> .0001) AND NECK LENGTH (OR, 4.15; P = .0146) WERE FOR AORTIC CUFF USE; CIRCUMFERENTIAL THROMBUS (OR, 2.44; P = .0448), AND NECK ANGLE (OR, 3.38; P = .009) WERE FOR PERIOPERATIVE COMPLICATIONS. CONCLUSIONS: PATIENTS WITH HNA CAN BE TREATED WITH EVAR, BUT WITH HIGHER RATES OF EARLY (INTRAOPERATIVE) TYPE I ENDOLEAK AND INTERVENTION. THE MIDTERM OUTCOMES ARE SIMILAR TO FNA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374561 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention