BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 5026144 · Received August 24, 2015

    Report

    Report Number
    2953200-2015-01410
    Event Type
    Injury
    Date Received
    August 24, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 3, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT DATES OF THE EVENTS ARE UNKNOWN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: CLINICAL OUTCOMES OF LEFT SUBCLAVIAN ARTERY COVERAGE ON MORBIDITY AND MORTALITY DURING THORACIC ENDOVASCULAR AORTIC REPAIR FOR DISTAL ARCH ANEURYSMS TAKESHI BABA, TAKAO OHKI, YUJI KANAOKA, KOJI MAEDA (WORLD J SURG, 2015, DOI 10.1007/S00268-015-3166-6) VALIANT AND TALENT STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF THORACIC ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: UNINTENTIONAL COVERAGE OF LCCA, CROSS-OVER BYPASS, CEREBRAL INFARCTION, PARAPLEGIA, BLUE TOE SYNDROME/CHOLESTEROL CRYSTAL EMBOLISM, INFECTION, STROKE, DEATH DUE TO ACUTE TYPE A DISSECTION, DEATH DUE TO ANEURYSM RUPTURE, DEATH DUE TO MYOCARDIAL INFARCTION, DEATH UNKNOWN CAUSE, TYPE IA ENDOLEAK, TYPE II ENDOLEAK, VERTEBROBASILAR INSUFFICIENCY, ILIAC ARTERY AND ASCENDING AORTA RUPTURE, MIGRATION, AORTOESOPHAGEAL FISTULA, ARM CLAUDICATION, UNKNOWN ENDOLEAK. ABSTRACT BACKGROUND THIS SINGLE-CENTER STUDY ASSESSED LEFT SUBCLAVIAN ARTERY (LSA REVASCULARIZATION MANAGEMENT AND MORBIDITY AND MORTALITY OF LSA COVERAGE OUTCOMES DURING ELECTIVE THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) FOR DISTAL ARCH ANEURYSMS. METHODS BETWEEN JULY 2006 AND JUNE 2014, 178 PATIENTS UNDERWENT TEVAR (ZONE 2 ? 3) FOR DISTAL ARCH ANEURYSMS. TEVAR WITH LSA COVERAGE (ZONE 2) WAS PERFORMED IN 121 PATIENTS(68.0 %). MULTIVARIATE ANALYSIS WAS PERFORMED TO DETERMINE FACTORS ASSOCIATED WITH PERIOPERATIVE CEREBRAL INFARCTION (CI) AND POSTOPERATIVE ENDOLEAK (EL). RESULTS TECHNICAL SUCCESS WAS ACHIEVED IN 96.7 %. LSA COIL EMBOLIZATION WAS PERFORMED IN 72.7 %. SUBCLAVIAN ARTERY CROSSOVER BYPASS WAS REQUIRED IN 9.1 %. PERIOPERATIVE COMPLICATIONS WERE CI (6.6 %) AND PARAPLEGIA (1.7 %). THE 30-DAY MORTALITY RATE WAS 2.5 % (N = 3). THERE WERE SIGNIFICANT DIFFERENCES BY CI UNIVARIATE ANALYSIS IN COVERAGE RANGE (C300 MM) (P = 0.003) AND SHAGGY AORTA (P = 0.044). PRIMARY EL OCCURRED IN 14.0 % (N = 17). WE FOUND STATISTICALLY SIGNIFICANT DIFFERENCE OF PRIMARY EL IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE (P = 0.016), PREOPERATIVE ANEURYSM DIAMETER (P = 0.041), AND PROXIMAL STENT GRAFT DIAMETER (P= 0.029). LEFT UPPER EXTREMITY SYMPTOMS DEVELOPED IN 5.8 % (N = 7); VERTEBROBASILAR INSUFFICIENCY OCCURRED IN 4.1 % (N = 5). FREEDOM FROM SECONDARY INTERVENTION RATES AFTER 1, 3, AND 5 YEARS WERE 96.1, 78.3, AND 63.4 %, RESPECTIVELY. CONCLUSIONS OUR MID- TO LONG-TERM RESULTS OF TEVAR WITH LSA COVERAGE WERE GENERALLY ACCEPTABLE. ROUTINE REVASCULARIZATION WAS NOT NECESSARY IN MAJORITY OF ZONE 2 TEVAR. CI OCCURRED IN APPROXIMATELY 6 % OF THE CASES, SECONDARY INTERVENTIONS WERE PERFORMED MORE OFTEN FOR ELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559173 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention