BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE

    MDR report key: 25228712 · Received May 20, 2026

    Report

    Report Number
    3004478276-2026-00144
    Event Type
    Death
    Date Received
    May 20, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 20, 2026
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWR
    UDI-DI
    08022057015396
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING AND MATERIAL RECORDS FOR THE DEVICE INVOLVED IN THIS EVENT, AS THEY PERTAIN TO THE REPORTED ISSUE, WERE RETRIEVED AND REVIEWED BY THE MANUFACTURER¿S QUALITY ENGINEERING. THE RESULTS CONFIRMED THAT THIS PROSTHESIS SATISFIED ALL REQUIRED MATERIAL, VISUAL, AND PERFORMANCE STANDARDS AT THE TIME OF MANUFACTURE AND RELEASE. THE MANUFACTURER IS FOLLOWING-UP WITH THE INVOLVED HEALTHCARE FACILITY TO RETRIEVE ADDITIONAL DETAILS ON THE EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON AVAILABILITY OF FURTHER INFORMATION FROM THE SITE.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS NOTIFIED OF THIS EVENT THROUGH MANTRA STUDY DATABASE. BASED ON THE AVAILABLE INFORMATION, A PERCEVAL PLUS VALVE (SIZE XL) WAS IMPLANTED IN A MALE PATIENT ON (B)(6) 2024 DURING A PROCEDURE THAT INCLUDED THREE CONCOMITANT CABG GRAFTS. THE PATIENT REPORTEDLY PASSED AWAY ON (B)(6) 2026. THE MANUFACTURER WAS INFORMED THAT THE PATIENT HAD NOT BEEN REACHABLE AT HOME FOR SEVERAL WEEKS PRIOR. THE PATIENT¿S MEDICAL HISTORY INCLUDED CORONARY ARTERY DISEASE, A MYOCARDIAL INFARCTION WITHIN 90 DAYS PRIOR TO THE PERCEVAL IMPLANTATION, TOBACCO USE, SEVERE CHRONIC LUNG DISEASE, AND NYHA CLASS IV STATUS AT THE TIME OF IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613011 PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR CORCYM S.R.L. PVF-XL 08022057015396

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Death