BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA

    MDR report key: 3214085 · Received July 9, 2013

    Report

    Report Number
    2953200-2013-01293
    Event Type
    Death
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2010
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (DEATH, ENDOLEAK, DISSECTION, ANEURYSM RUPTURE, STROKE, MI, RENAL FAILURE, PARALYSIS, ISCHEMIA); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVELY DISSECTED THORACIC AORTA); UNAPPROVED USE OF DEVICE (STENT GRAFT WAS IMPLANTED IN A PATIENT WITH A PRE-OPERATIVELY DISSECTED THORACIC AORTA. CONCLUSION: INHERENT RISK OF A PROCEDURE (DEATH, ENDOLEAK, DISSECTION, ANEURYSM RUPTURE, STROKE, MI, RENAL FAILURE, PARALYSIS, ISCHEMIA); DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVELY DISSECTED THORACIC AORTA); OFF LABEL, UNAPPROVED OR CONTRAINDICATED USE (STENT GRAFT WAS IMPLANTED IN A PATIENT WITH A PRE-OPERATIVELY DISSECTED THORACIC AORTA).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: THORACIC ENDOVASCULAR AORTIC REPAIR FOR ACUTE COMPLICATED TYPE B AORTIC DISSECTION: SUPERIORITY RELATIVE TO CONVENTIONAL OPEN SURGICAL AND MEDICAL THERAPY. J THORAC CARDIOVASC SURG 2010;140:S109-15. ON AN UNKNOWN DATE UNKNOWN TALENT THORACIC STENT GRAFTS WERE IMPLANTED BETWEEN 2002 AND 2010. OBJECTIVE: THIS STUDY COMPARED OUTCOMES BETWEEN THORACIC ENDOVASCULAR AORTIC REPAIR AND CONVENTIONAL OPEN SURGICAL AND MEDICAL THERAPIES FOR ACUTE COMPLICATED TYPE B AORTIC DISSECTION. METHODS: FROM 2002 TO 2010, A TOTAL OF 170 PATIENTS WITH TYPE B AORTIC DISSECTIONS WERE RETROSPECTIVELY IDENTIFIED FROM THE UNIVERSITY OF PENNSYLVANIA AORTIC DATABASE. OF THESE 170 PATIENTS, 147 HAD ACUTE TYPE B AORTIC DISSECTIONS (UNCOMPLICATED 70, COMPLICATED 77). FOR PATIENTS WITH ACUTE COMPLICATED TYPE B AORTIC DISSECTIONS, MANAGEMENT INCLUDED THORACIC ENDOVASCULAR AORTIC REPAIR (GROUP A) OR CONVENTIONAL OPEN SURGICAL AND MEDICAL THERAPIES (GROUP B). RESULTS: IN THE 77 PATIENTS WITH ACUTE COMPLICATED TYPE B AORTIC DISSECTIONS, THORACIC ENDOVASCULAR AORTIC REPAIR (GROUP A) WAS PERFORMED IN 45 PATIENTS (59%). IN GROUP B, 20 PATIENTS (26%) UNDERWENT OPEN SURGICAL REPAIR AND 12 (15%) HAD THEIR CONDITIONS MANAGED WITH MEDICAL THERAPY. THORACIC ENDOVASCULAR AORTIC REPAIR WAS ASSOCIATED WITH LOWER IN-HOSPITAL OR 30-DAY MORTALITY (N = 2, 4%) THAN CONVENTIONAL THERAPY (OPEN SURGICAL REPAIR N = 8, 40%, MEDICAL THERAPY, N=4, 33%, P=.006). PATIENTS IN GROUPA (THORACIC ENDOVASCULAR AORTIC REPAIR) CONTINUED TO SHOW SIGNIFICANTLY IMPROVED SURVIVAL AT 1, 3, AND 5 YEARS (GROUP A: 82%, 79%, AND 79% VS GROUP B: 58%, 52%, AND 44%, P = .008). CONCLUSIONS: THORACIC ENDOVASCULAR AORTIC REPAIR FOR ACUTE COMPLICATED TYPE B DISSECTION IS ASSOCIATED WITH SUPERIOR EARLY OUTCOME AND IMPROVED MIDTERM SURVIVAL RELATIVE TO CONVENTIONAL THERAPY. LONGER FOLLOW-UP DEMONSTRATING SURVIVAL BENEFIT IS NEEDED BEFORE DEFINITIVE CONCLUSION CAN BE MADE. THE FOLLOWING EVENTS WERE REPORTED: DISSECTION, DEATH, RUPTURE, ENDOLEAK, STROKE, MI, RENAL FAILURE, ISCHEMIA, PARALYSIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312721 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention