BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 4783080 · Received May 19, 2015

    Report

    Report Number
    2953200-2015-00914
    Event Type
    Death
    Date Received
    May 19, 2015
    Date of Event
    October 7, 2011
    Report Date
    April 29, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. MIDTERM COST AND EFFECTIVENESS OF THORACIC ENDOVASCULAR AORTIC REPAIR VERSUS OPEN REPAIR ASHKAN KARIMI, MD, KAREN L. WALKER, MD, MHS, TOMAS D. MARTIN, MD, PHILIP J. HESS, MD, CHARLES T. KLODELL, MD, ROBERT J. FEEZOR, MD, ADAM W. BECK, MD, AND THOMAS M. BEAVER, MD, MPH. (ANN THORAC SURG 2012;93:473-9) THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH, STROKE, PARAPARESIS OR PARALYSIS, RENAL FAILURE, WOUND INFECTION, SEPSIS, BLEEDING, TYPE I LEAK, TYPE II LEAK. BACKGROUND. THORACIC ENDOVASCULAR ANEURYSM REPAIR (TEVAR) HAS BEEN RAPIDLY INTRODUCED AS A PRIMARY TREATMENT MODALITY FOR THORACIC AORTIC DISEASES WITH LIMITED DATA AVAILABLE ON MIDTERM TO LATE-TERM OUTCOMES. METHODS. A RETROSPECTIVE SINGLE INSTITUTION STUDY COMPARING HOSPITAL AND MIDTERM OUTCOMES AND COSTS FOR TEVAR VERSUS OPEN ELECTIVE REPAIR OF DESCENDING THORACIC ANEURYSMS WAS CONDUCTED. FIFTY-SEVEN PATIENTS WERE INCLUDED BETWEEN 2005 AND 2007 (TEVAR - 28; OPEN - 29) AND WERE FOLLOWED UNTIL MAY 2010. RESULTS. PATIENTS IN THE TEVAR GROUP WERE OLDER (73.2 VERSUS 62.3 YEARS; P <(> <<)> 0.001). HOSPITAL MORTALITY WAS HIGHER IN THE OPEN REPAIR GROUP (10.3% VERSUS 3.6%; P _0.611). THERE WAS NO STATISTICAL DIFFERENCE IN STROKE, PARAPARESIS OR PARALYSIS, SEPSIS, OR RENAL FAILURE; HOWEVER, A COMPOSITE MAJOR ADVERSE EVENT VARIABLE SHOWED A HIGHER COMPLICATION WITH OPEN REPAIR VERSUS TEVAR (37.9% VERSUS 14.3%; P _ 0.043). MEAN FOLLOW-UP WAS 42.6MONTHS FOR OPEN REPAIR VERSUS 26.9 FOR TEVAR (P _0.002). KAPLAN-MEIER SURVIVAL ANALYSIS SHOWED THE INITIAL SURVIVAL BENEFIT FOR TEVAR WAS LOST IN LESS THAN 6 MONTHS; HOWEVER, THE DIFFERENCE DID NOT REACH STATISTICAL SIGNIFICANCE DURING FOLLOW-UP (LOG-RANK TEST P _ 0.232). MEAN SURVEILLANCE IMAGING COSTS FOR A TEVAR PATIENT WERE $1,800.38 HIGHER THAN FOR AN OPEN PATIENT AT 2 YEARS. COMPLIANCE OF TEVAR PATIENTS WITH FOLLOW-UP IMAGING WAS 78%, 64%, 50%, AND 42% AT 1, 6, 12, AND 24 MONTHS, RESPECTIVELY, AND WAS EVEN LOWER IN THOSE NOT REGISTERED IN DEVICE TRIALS. CONCLUSIONS. PATIENTS IN THE TEVAR GROUP HAD FAVORABLE EARLY OUTCOMES; HOWEVER, MIDTERM SURVIVAL WAS REDUCED SECONDARY TO COMORBIDITIES. THIS STUDY RAISES CONCERN FOR THE ONGOING COSTS OF SURVEILLANCE IMAGING IN TEVAR AS WELL AS PATIENT COMPLIANCE WITH FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324540 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention