BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA

    MDR report key: 3725132 · Received April 3, 2014

    Report

    Report Number
    2953200-2014-00623
    Event Type
    Death
    Date Received
    April 3, 2014
    Date of Event
    February 27, 2013
    Report Date
    March 7, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: SYSTEMATIC REVIEW OF OUTCOMES OF COMBINED PROXIMAL STENT GRAFTING WITH DISTAL BARE STENTING FOR MANAGEMENT OF AORTIC DISSECTION. LUDOVIC CANAUD, MD, PHD, BENJAMIN O. PATTERSON, BSC, GEORGE PEACH, MRCS, ROBERT HINCHLIFFE, MD, FRCS, IAN LOFTUS, MD, FRCS, AND MATT M. THOMPSON, MD, FRCS. J THORAC CARDIOVASC SURG 2013VOLUME 145, ISSUE 6, JUNE 2013, PAGES 1431¿1438. ACCEPTED FOR PUBLICATION FEB 27, 2013. THE FOLLOWING EVENTS WERE OBSERVED IN THIS JOURNAL ARTICLE. ACUTE AND CHRONIC DISSECTIONS, ENDOLEAK, TYPE I ENDOLEAK, RETROGRADE TYPE I DISSECTION, RETROGRADE DISSECTION, ACUTE RENAL FAILURE, AORTIC RUPTURE, STROKE, PARAPARESIS OR PARAPLEGIA, SPINAL CORD ISCHEMIA WITH PERMANENT DEFICIT, RENAL FAILURE, BOWEL ISCHEMIA, CARDIAC FAILURE, PULMONARY DISTRESS SYNDROME OR SEVERE LUNG INFECTION, BOWEL ISCHEMIA, AORTO-BRONCHIAL FISTULA, AND UNPLANNED RETURN TO SURGERY. THERE IS NO FURTHER INFORMATION AVAILABLE. OBJECTIVE: AVAILABLE DATA ON OUTCOMES OF COMBINED PROXIMAL STENT GRAFTING WITH DISTAL BARE STENTING FOR MANAGEMENT OF AORTIC DISSECTION ARE LIMITED. THIS IS A SYSTEMATIC REVIEW OF OUTCOMES OF THIS APPROACH. METHODS: STUDIES INVOLVING COMBINED PROXIMAL STENT GRAFTING WITH DISTAL BARE STENTING FOR MANAGEMENT OF AORTIC DISSECTION WERE SYSTEMATICALLY SEARCHED AND REVIEWED. RESULTS: A TOTAL OF 4 STUDIES WERE INCLUDED, WITH 108 PATIENTS TREATED FOR ACUTE (N ¼ 54) AND CHRONIC (N ¼ 54) AORTIC DISSECTION. TECHNICAL SUCCESS RATE WAS 95.3% (RANGE, 84-100). THE 30-DAY MORTALITY WAS 2.7% (RANGE, 0%-5%). MORBIDITY RATE WITHIN 30 DAYS WAS 51.8% (RANGE, 0%-65%) AND INCLUDED STROKE (2.7%), PARAPLEGIA (2.7%), RETROGRADE DISSECTION (1.8%), RENAL FAILURE (14.8%), SEVERE CARDIOPULMONARY COMPLICATIONS (5.5%), AND BOWEL ISCHEMIA (0.9%). INCIDENCE OF TYPE I ENDOLEAK WAS 9.2% (10/108). DURING FOLLOW-UP, 5 PATIENT DEATHS (4.6%) WERE RELATED TO AORTIC RUPTURE OR AORTIC REPAIR. REINTERVENTION RATE WAS FROM 12.9%. TWO CASES OF DELAYED RETROGRADE TYPE A DISSECTION (1.9%) AND 1 CASE OF AORTOBRONCHIAL FISTULA (0.9%) WERE REPORTED. MOST COMMON DELAYED COMPLICATION WAS THORACIC STENT-GRAFT MIGRATION (4.7%). DEVICE FAILURE RATE WAS 9.2%. FAVORABLE AORTIC REMODELING WAS OBSERVED: STUDIES REPORTING MIDTERM FOLLOW-UP OF THE TRUE LUMEN DEMONSTRATED HIGH RATES OF FALSE-LUMEN REGRESSION AND TRUE-LUMEN EXPANSION. AT 12 MONTHS, COMPLETE FALSE-LUMEN THROMBOSIS WAS OBSERVED AT THE THORACIC LEVEL IN 70.4% AND AT THE ABDOMINAL LEVEL IN 13.5%. CONCLUSIONS: COMBINED PROXIMAL STENT GRAFTING WITH DISTAL BARE STENTING FOR MANAGEMENT OF AORTIC DISSECTION APPEARS TO BE A REASONABLE APPROACH FOR TYPE B AORTIC DISSECTION, CLEARLY IMPROVED TRUE-LUMEN PERFUSION AND DIAMETER ALTHOUGH FAILING TO SUPPRESS FALSE-LUMEN PATENCY COMPLETELY. CONTEMPORARY INFORMATION ON THIS APPROACH IS MAINLY PROVIDED BY SMALL SERIES WITH A WIDE RANGE OF RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201813 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Death