BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT

    MDR report key: 3217170 · Received July 10, 2013

    Report

    Report Number
    2953200-2013-01311
    Event Type
    Death
    Date Received
    July 10, 2013
    Date of Event
    July 26, 2011
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSIONS: (PRE-OPERATIVE DISSECTION OF THORACIC AORTA, PRE-OPERATIVE RUPTURE). (STROKE, DEATH, MI, HEART FAILURE, ISCHEMIA). (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN). (STENT GRAFT SCALLOPING).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. ENDOVASCULAR STENT GRAFT REPAIR OF AORTIC DISSECTION TYPE B EXTENDING TO THE AORTIC ARCH. Q. LU, Z. JING, Z. ZHAO, J. BAO, X. FENG, R. FENG, Z. MEI. (EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, VOLUME 42, ISSUE 4, PAGES 456-463). AVAILABLE ONLINE 26-JUL-2011. DOI:10.1016/J.EJVS.2011.06.050 ABSTRACT OBJECTIVE: TO ANALYSE OUR EXPERIENCE WITH ENDOVASCULAR STENT GRAFT REPAIR OF DESCENDING AORTA DISSECTIONS THAT REQUIRE SUPRAAORTIC BRANCH VESSEL REVASCULARISATION. DESIGN: RETROSPECTIVE STUDY. METHODS: FROM 2001 TO 2009, 22 CONSECUTIVE PATIENTS WITH THE ABOVE DISSECTIONS WERE RETROSPECTIVELY ANALYSED. INCLUSION REQUIREMENT: AORTIC LANDING ZONE PROXIMAL TO THE LEFT SUBCLAVIAN ARTERY OF LESS THAN 15 MM. HYBRID, SCALLOPED OR FENESTRATED ENDOVASCULAR STENT GRAFTS WERE SELECTED BASED ON DISSECTION CHARACTERISTICS. ANNUAL FOLLOW-UP VISITS (MEDIAN 27.1 MONTHS) INCLUDED COMPUTED TOMOGRAPHY ANGIOGRAPHY. END POINTS INCLUDE PROGRESSIVE PATHOLOGY, COMPLICATIONS AND SURVIVAL RATES. RESULTS: SURGERY WAS SUCCESSFUL IN ALL EXCEPT FOR ONE OPERATIVE COMPLICATION. TWO PATIENTS DIED WITHIN 30 DAYS AFTER SURGERY, ONE TO CEREBRAL INFARCTION AND THE OTHER TO MYOCARDIAL INFARCTION. NO POSTOPERATIVE COMPLICATIONS OCCURRED IN THE REMAINING PATIENTS. THROMBOSIS FORMED IN THE AORTIC FALSE LUMEN OF THE GRAFT EXCLUSION SEGMENT IN ALL PATIENTS. THE MAXIMUM DIAMETER OF THIS SEGMENT DECREASED IN 18 PATIENTS AND WAS STABLE IN TWO. IN 19 PATIENTS, BLOOD FLOW REMAINED IN THE FALSE LUMEN DISTAL TO THE EXCLUSION AREA NOT COVERED BY STENT. PATENCY WAS SEEN AT MID- AND LONG-TERM FOLLOW-UP, WITHOUT PROXIMAL ENDOLEAK, GRAFT DISPLACEMENT OR DEATHS. CONCLUSION: ENDOVASCULAR STENT GRAFT METHODS SHOW PROMISE IN ENDOVASCULAR STENT GRAFT REPAIR OF PROXIMAL DESCENDING AORTIC DISSECTIONS INVOLVING THE DISTAL ARCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315366 TALENT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Death| R