BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA VALVE,IDE,23MM

    MDR report key: 6432701 · Received March 24, 2017

    Report

    Report Number
    8020430-2017-00004
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    January 11, 2017
    Report Date
    June 29, 2017
    Manufacturer
    ST. JUDE MEDICAL CANADA, INC.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH ABBOTT SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION CONCLUDED ALL THREE LEAFLETS CONTAINED TEARS AND CALCIFICATIONS. THERE WAS A HORIZONTAL FOLD RESULTING IN INCOMPLETE COAPTATION IN LEAFLET 2. THERE WAS FIBROUS PANNUS INGROWTH ON THE INFLOW SURFACE OF LEAFLET 1. NO ACUTE INFLAMMATION WAS PRESENT IN THE VALVE. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE CAUSE OF THE PANNUS, CALCIFICATION, AND TEARS WERE DUE TO AN INTRINSIC DEFECT IN THE VALVE, AS SUPPORTED BY REVIEW OF THE VALVE'S DEVICE HISTORY RECORD AND THE ANALYSIS PERFORMED. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2008, A 23 MM TRIFECTA VALVE WAS IMPLANTED. ON (B)(6) 2017, SEVERE (4+) AORTIC VALVE REGURGITATION WAS NOTED. FINDINGS INCLUDED A PEAK GRADIENT OF 35 MMHG (PEAK VELOCITY = 294.0 CM/S), WITH MEAN GRADIENT OF 20 MMHG. THE LVOT MEAN VELOCITY WAS 68.8 CM/S, WITH THE LVOT DIAMETER OF 2.1 CM, AND AN AORTIC VTI OF 71.0 CM. THE MEAN VELOCITY IN THE AORTIC VALVE IS 206.0 CM/S, WITH A DIMENSIONLESS VALVE INDEX OF 0.36, AV AREA IS 1.23 CM² (0.57 CM²/M²) BY CONTINUITY, VTI, AND LVOT STROKE VOLUME INDEX IS 42 ML/M². GIVEN THE DILATED LV WITH LOW NORMAL LVEF ON MRI THE PATIENT IS SCHEDULED FOR REOPERATION IN THE NEXT FEW MONTHS. THE PATIENT IS REPORTED TO BE STABLE. (CLINICAL STUDY PATIENT (B)(6)).

    Description of Event or Problem · 1

    ON (B)(6) 2008, A 23 MM TRIFECTA VALVE WAS IMPLANTED. ON (B)(6) 2017, SEVERE (4+) AORTIC VALVE REGURGITATION WAS NOTED. FINDINGS INCLUDED A PEAK GRADIENT OF 35 MMHG (PEAK VELOCITY = 294.0 CM/S), WITH MEAN GRADIENT OF 20 MMHG. THE LVOT MEAN VELOCITY WAS 68.8 CM/S, WITH THE LVOT DIAMETER OF 2.1 CM, AND AN AORTIC VTI OF 71.0 CM. THE MEAN VELOCITY IN THE AORTIC VALVE IS 206.0 CM/S, WITH A DIMENSIONLESS VALVE INDEX OF 0.36, AV AREA IS 1.23 CM² (0.57 CM²/M²) BY CONTINUITY, VTI, AND LVOT STROKE VOLUME INDEX IS 42 ML/M². ON (B)(6) 2017, THE VALVE WAS EXPLANTED AND REPLACED WITH A 23 MM TRIFECTA GT VALVE. THE PATIENT WAS DISCHARGED ON (B)(6) 2017 IN STABLE CONDITION. (CLINICAL STUDY PATIENT ID: (B)(6))

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213053 TRIFECTA VALVE,IDE,23MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL CANADA, INC. TF-23A-IDE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R