BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA

    MDR report key: 3213237 · Received July 9, 2013

    Report

    Report Number
    2953200-2013-01281
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    January 1, 2011
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN. (B)(4). RESULTS: ENDOLEAK, ISCHEMIA, OCCLUSION. UNKNOWN CAUSE OF EVENT. COVERAGE OF THE LCC AND INNOMINATE ARTERY. CONCLUSION: UNKNOWN CAUSE OF EVENT. ENDOLEAK, ISCHEMIA, OCCLUSION. COVERAGE OF THE LCC AND INNOMINATE ARTERY.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: MANAGEMENT WITH THE INSUFFICIENT PROXIMAL LANDING ZONE FOR ENDOVASCULAR REPAIR IN AORTIC DISSECTION. MA HAO, YANG HONG-YU, ZOU JUN-JIE AND ZHANG XI-WEI; (CHIN MED J 2011;124(19):3003-3007) ON AN UNKNOWN DATE BETWEEN AUGUST 2005 AND FEBRUARY 2010, AN UNKNOWN TALENT STENT GRAFT WAS IMPLANTED. DURING A RETROSPECTIVE STUDY OF 24 PATIENTS (FROM A STUDY OF 129) TREATED FOR THORACIC ENDOVASCULAR AORTIC REPAIR, THE FOLLOWING EVENTS WERE OBSERVED: PRE-OP DISSECTION, SNORKEL TECHNIQUE, INTENTIONAL VESSEL COVERAGE, TYPE I ENDOLEAK (ACUTE), THROMBOSIS OF THE STENT GRAFT, ISCHEMIA, DIZZINESS, GIDDINESS AND HEADACHE . NO ADDITIONAL INFORMATION IS AVAILABLE. BACKGROUND SUFFICIENT LENGTH OF THE PROXIMAL LANDING ZONE (PLZ) IS THE KEY FOR A SUCCESSFUL THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) OF AN AORTIC LESION. THE AIM OF THIS RESEARCH WAS TO INVESTIGATE THE SAFETY, FEASIBILITY, EFFICACY, AND PROBLEMS OF ENDOVASCULAR REPAIR FOR AORTIC DISSECTION WITH INSUFFICIENT PLZ. METHODS THE CLINICAL DATA BETWEEN AUGUST 2005 AND FEBRUARY 2010 FROM PATIENTS WITH INSUFFICIENT PLZ FOR ENDOVASCULAR REPAIR OF AORTIC DISSECTION WERE RETROSPECTIVELY REVIEWED. ACCORDING TO THE CLASSIFICATION PROPOSED BY ISHIMARU, AORTIC ZONE 0 WAS INVOLVED IN 3 CAS ES, ZONE 1 IN 10 CASES, AND ZONE 2 IN 11 CASES. A HYBRID SURGICAL PROCEDURE OF SUPRAAORTIC DEBRANCHING AND REVASCULARIZATION, DIRECTLY COVERAGE THE ORIFICE OF LEFT SUBCLAVIAN ARTERY, OR A LEFT COMMON CAROTID ARTERY CHIMNEY GRAFT TECHNIQUE WERE PERFORMED TO OBTAIN AN ADEQUATE PROXIMAL AORTIC LANDING ZONE. RESULTS THERE WAS NO SIGNIFICANT DIFFERENCE IN RISK FACTORS AND DIAMETER OF THE PLZ BETWEEN ZONE 0, ZONE 1, AND ZONE 2. BUT THE LENGTH OF THE PLZ WAS SIGNIFICANTLY DIFFERENT IN THE THREE GROUPS (P <(><<)>0.01). THERE WAS NO SIGNIFICANT DIFFERENCE IN TECHNICAL AND CLINICAL SUCCESS RATE BETWEEN THE GROUPS. CONCLUSIONS THE PROCEDURE FOR EXTENDING AN INSUFFICIENT PLZ FOR ENDOVASCULAR REPAIR FOR AORTIC ARCH PATHOLOGYIS FEASIBLE AND RELATIVELY SAFE. THE APPLICABILITY OF TEVAR IN SUCH AORTIC DISORDERS MAY BE EXPANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311918 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention