BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE

    MDR report key: 18026016 · Received October 27, 2023

    Report

    Report Number
    3019892983-2023-01017
    Event Type
    Death
    Date Received
    October 27, 2023
    Date of Event
    September 28, 2023
    Report Date
    October 27, 2023
    Manufacturer
    CORCYM CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000818
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY DATABASE. REPORTEDLY, A PERCEVAL PLUS VALVE SIZE L WAS IMPLANTED IN THE PATIENT ON (B)(6) 2023. BASED ON INFORMATION RECEIVED, PATIENT HAD HEMORRHAGIC SHOCK- CARDIAC ARREST ON (B)(6) 2023. THE PATIENT WENT INTO PEA DURING EGD - HYPOTENSION AND ANESTHESIA, ACUTE RESPIRATORY FAILURE AND INTUBATED AT THE TIME OF CODE. THE PATIENT UNDERWENT DIAGNOSTIC TESTS AND TRANSFUSION, BUT EVENTUALLY PASSED AWAY ON (B)(6) 2023. AS REPORTED, THE PATIENT'S CLINICAL HISTORY INCLUDED CORONARY ARTERY DISEASE; ARRHYTHMIA: ATRIAL FIBRILLATION; CARDIAC CONDUCTION DISORDER: RBBB; SYSTEMIC HYPERTENSION; AND DYSLIPIDEMIA. FURTHERMORE, PATIENT WENT UNDER ATRIAL FIBRILLATION TREATMENT IN 2003, AND WAS NYHA CLASS II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154202 PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR CORCYM CANADA CORP. PVF-L 00896208000818

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Death