BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM TRIFECTA VALVE

    MDR report key: 4213469 · Received October 30, 2014

    Report

    Report Number
    8020430-2014-00011
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 1, 2014
    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 THIS INVESTIGATION CONCLUDED FIBROUS THICKENING OF ALL CUSPS, NODULAR CALCIFICATIONS WITHIN THE TISSUE OF EACH CUSP, FIBROUS PANNUS INGROWTH ON THE OUTFLOW SURFACE OF CUSPS 2 AND 3, AND A TEAR IN CUSP 1. SPECIAL STAINS WERE NEGATIVE FOR ORGANISMS, AND NO ACUTE INFLAMMATION WAS PRESENT. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE CAUSE OF THE FIBROUS THICKENING, PANNUS FORMATION, CALCIFICATION FORMATION, AND CUSPAL TEAR 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 FIBROUS THICKENING, PANNUS FORMATION, CALCIFICATION FORMATION, AND CUSPAL TEAR REMAINS UNKNOWN.

    Description of Event or Problem · 1

    ECHOCARDIOGRAMS REVEALED ELEVATED GRADIENTS AND STENOSIS CAUSED BY CALCIFICATION. RE-DO AORTIC VALVE REPLACEMENT AND TRICUSPID VALVE REPAIR WAS PERFORMED. DURING THE EXPLANT PROCEDURE, STENOSIS AND CALCIFICATION WERE OBSERVED ON THE VALVE. A 23 MM PERICARDIAL VALVE FROM ANOTHER MANUFACTURER WAS IMPLANTED. A PERMANENT PACEMAKER WAS IMPLANTED ON (B)(6) 2014 DUE TO COMPLETE HEART BLOCK. THE HOSPITAL'S PATHOLOGY REPORT NOTED CALCIFICATION, MODERATE PANNUS, AN AREA CONSISTENT WITH A TEAR, AND ONE CUSP WITH LIMITED MOBILITY. IT WAS REPORTED THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695449 SJM TRIFECTA VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL CANADA, INC. TF-23A-IDE 0002684687

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R