BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 12397765 · Received August 31, 2021

    Report

    Report Number
    3004478276-2021-00211
    Event Type
    Injury
    Date Received
    August 31, 2021
    Report Date
    October 15, 2021
    Manufacturer
    CORCYM CANADA CORP.
    Product Code
    LWR
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER ATTEMPTED TO RETRIEVE ADDITIONAL INFORMATION ON THE REPORTED EVENT. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED TO DATE. SINCE THE DEVICE SERIAL NUMBER IS UNKNOWN AND ITS DISPOSITION IS UNKNOWN (DEVICE NOT RETURNED TO THE MANUFACTURER), NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. BASED ON THE LIMITED INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO ESTABLISH A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT. IT SHOULD BE NOTED THAT ENDOCARDITIS IS LISTED AS A POSSIBLE ADVERSE EVENT IN THE PERCEVAL IFU. THE EVENT IS, THEREFORE, A KNOWN INHERENT RISK OF THE DEVICE. AS NO FURTHER INVESTIGATION IS POSSIBLE, THE MANUFACTURER WILL PROCEED WITH THE CASE CLOSURE AT THIS TIME. SHOULD THE MANUFACTURER RECEIVE ADDITIONAL INFORMATION IN THE FUTURE, AN UPDATE TO THIS REPORTING ACTIVITY WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE PUBLICATION "ENDOCARDITIS ON A PERCEVAL S SUTURELESS PROSTHESIS. A NEW VALVE WITH A NEW FORM OF CLINICAL PRESENTATION" BY GROBA-MARCO ET AL. BASED ON THE INFORMATION REPORTED IN THE PAPER, INFECTIOUS ENDOCARDITIS IS A DISEASE WITH HIGH MORBIDITY AND MORTALITY, THE MOST SEVERE FORM BEING PROSTHETIC VALVULAR ENDOCARDITIS (PVE). THE AUTHORS OF THE PAPER PERFORMED A RETROSPECTIVE OBSERVATIONAL STUDY TO ANALYZE THE PREVALENCE AND PRESENTING CHARACTERISTICS OF PVE IN THE PERCEVAL PROSTHESIS, WITH PARTICULAR ATTENTION PAID TO DIAGNOSTIC IMAGING. SINCE 2015, 670 PERCEVAL S VALVES HAVE BEEN IMPLANTED AND 14 CASES OF PVE HAVE BEEN DIAGNOSED IN THEM. THIS CASE REFERS TO A PATIENT WHO RECEIVED A PERCEVAL PVS23 VALVE. THE PATIENT DEVELOPED PVE 3 MONTHS AFTER THE IMPLANT OF THE PVS23 VALVE, LEADING TO RE-INTERVENTION. THE MICROORGANISM WAS IDENTIFIED AS VIRIDANS GROUP STREPTOCOCCUS. THE PRE-OPERATIVE TEE SHOWED IC - MITRO-AORTIC THICKENING, WITH NO VEGETATION AND NO PERIPROSTHETIC LEAK. THE PET/CT SCAN SHOWED ABSCESS. AT THE TIME OF THE RE-INTERVENTION, A NEW PERCEVAL MODEL PVS23 VALVE WAS IMPLANTED AFTER PATCHING THE AORTIC ANNULUS WITH BOVINE PERICARDIUM. THE PATIENT SURVIVED AFTER THE SURGERY.

    Additional Manufacturer Narrative · 1

    UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    THIS CASE REFERS TO PT # 12 OF 14 : BASED ON INFORMATION RECEIVED FROM THE PAPER "ENDOCARDITIS ON A PERCEVAL S SUTURELESS PROSTHESIS. A NEW VALVE WITH A NEW FORM OF CLINICAL PRESENTATION" BY M.V. GROBA-MARCO. THE PATIENT WAS SUFFERING FROM PROSTHETIC VALVULAR ENDOCARDITIS (PVE). A PERCEVAL PVS 23MM WAS IMPLANTED. AFTER 3 MONTHS OF IMPLANTATION AN ECHO SHOWED THE PATIENT HAD SIGNS OF AORTIC THICKENING AND ABSCESS. THE PATIENT REQUIRED SURGICAL INTERVENTION AND A NEW PERCEVAL VALVE 23 AND A PATCH WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291764 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR CORCYM CANADA CORP. PVS23

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention