BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MASTERS SERIES FLEX CUFF HEMODYNAMIC PLUS

    MDR report key: 2792285 · Received October 12, 2012

    Report

    Report Number
    2648612-2012-00055
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON FOLLOW-UP ECHO, A HIGH GRADIENT WAS NOTED AND FLUOROSCOPY REVEALED BOTH LEAFLETS APPEARED TO BE SOMEWHAT IMPINGED. THE VALVE WAS EXPLANTED AND DURING THE PROCEDURE, IT WAS NOTED THAT PLEDGETS MAY HAVE BEEN PREVENTING COMPLETE LEAFLET OPENING. THE VALVE WAS REPLACED WITH A 19 MM SJM REGENT VALVE. THE PT WAS REPORTED TO BE STABLE POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM MASTERS SERIES FLEX CUFF HEMODYNAMIC PLUS ROTATABLE HEART VALVE LWQ ST. JUDE MEDICAL PUERTO RICO, INC (CS) 19AFHPJ-505

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R