BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT

    MDR report key: 3217383 · Received July 10, 2013

    Report

    Report Number
    2953200-2013-01331
    Event Type
    Death
    Date Received
    July 10, 2013
    Date of Event
    June 28, 2011
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVE DISSECTION OF THORACIC AORTA, PRE-OPERATIVE RUPTURE, PRE-OPERATIVE TRANSECTION). INHERENT RISK OF PROCEDURE (ISCHEMIA, PARALYSIS, STROKE, RENAL FAILURE, INFECTION, DEATH, DISSECTION, MIGRATION, OCCLUSION, ENDOLEAK, RUPTURE, COAGULOPATHY, SEPSIS, OPEN SURGICAL REPAIR). CONCLUSIONS: DEVICE FAILURE RELATED TO PATIENT CONDITION (PRE-OPERATIVE DISSECTION OF THORACIC AORTA, PRE-OPERATIVE RUPTURE, PRE-OPERATIVE TRANSECTION) KNOWN INHERENT RISK OF A PROCEDURE (ISCHEMIA, PARALYSIS, STROKE, RENAL FAILURE, INFECTION, DEATH, DISSECTION, MIGRATION, OCCLUSION, ENDOLEAK, RUPTURE, COAGULOPATHY, SEPSIS, OPEN SURGICAL REPAIR).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. LATE OUTCOMES OF A SINGLE-CENTER EXPERIENCE OF 400 CONSECUTIVE THORACIC ENDOVASCULAR AORTIC REPAIRS. W. ANTHONY LEE, MD; MICHAEL J. DANIELS, SCD; THOMAS M. BEAVER, MD; CHARLES T. KLODELL, MD; DAN E. RAGHINARU, MS; PHILIP J. HESS, JR, MD. (CIRCULATION. 2011;123:2938-2945). DOI:10.1161/CIRCULATIONAHA.110.965756 BACKGROUND¿IN THIS STUDY, WE REPORT THE LATE OUTCOMES OF A LARGE, DECADE-LONG SINGLE-CENTER THORACIC ENDOVASCULAR AORTIC REPAIR EXPERIENCE. METHODS AND RESULTS¿A PROSPECTIVELY MAINTAINED REGISTRY AND THE ELECTRONIC MEDICAL RECORDS OF 400 CONSECUTIVE THORACIC ENDOVASCULAR AORTIC REPAIR PERFORMED AT A (B)(6) WERE REVIEWED. THE DISTRIBUTION OF PATHOLOGIES TREATED INCLUDED ANEURYSMS (198, 49%), DISSECTIONS (100, 25%), PENETRATING ULCERS (54, 14%), TRAUMATIC TRANSECTIONS (25, 6%), AND OTHER PATHOLOGIES (23, 6%). SPINAL DRAINS WERE PLACED PROPHYLACTICALLY IN 127 CASES (32%) OF PLANNED EXTENDED AORTIC COVERAGE. THERE WERE NO ACUTE SURGICAL CONVERSIONS. ADJUNCTIVE SURGICAL PROCEDURES WERE PERFORMED ON 94 PATIENTS (24%). SUBCLAVIAN REVASCULARIZATIONS WERE PERFORMED SELECTIVELY IN ONLY 15% OF ZONE 0 TO 2 DEPLOYMENTS. THE MEDIAN LENGTH OF STAY WAS 5 DAYS (LIMITS, 1 AND 79 DAYS). OVERALL 30-DAY MORTALITY WAS 6.5% (ELECTIVE, 2.6%; URGENT, 9.5%; AND EMERGENT, 20%). PERMANENT SPINAL CORD ISCHEMIA OCCURRED IN 4.5% AND STROKE IN 3%. KAPLAN-MEIER ESTIMATES OF SURVIVAL WERE 82%, 76%, 68%, AND 60% AND FREEDOM FROM SECONDARY INTERVENTION WAS 90%, 86%, 81%, AND 78% AT 6, 12, 24, AND 36 MONTHS, RESPECTIVELY. RISK FACTORS FOR MORTALITY INCLUDED STROKE, URGENT/EMERGENT REPAIR, AGE 80 YEARS, GENERAL ANESTHESIA, AND DISSECTION PATHOLOGY. CONCLUSIONS¿THORACIC ENDOVASCULAR AORTIC REPAIR MAY BE USED TO TREAT A VARIETY OF THORACIC AORTIC PATHOLOGIES WITH A VERY LOW RISK OF INTRAOPERATIVE CONVERSION. OVERALL RATES OF MORTALITY AND NEUROLOGICAL COMPLICATIONS WERE RELATIVELY LOW BUT SIGNIFICANTLY INCREASED IN EMERGENT REPAIRS. THERE APPEARED TO BE A SUBSTANTIAL NUMBER OF LATE DEATHS, WHICH MAY REPRESENT A COMBINATION OF POOR PATIENT SELECTION AND TREATMENT FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315921 TALENT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Death| R