BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL PLUS SUTRUELESS AORTIC HEART VALVE

    MDR report key: 21460257 · Received February 25, 2025

    Report

    Report Number
    3004478276-2025-00122
    Event Type
    Injury
    Date Received
    February 25, 2025
    Date of Event
    April 10, 2024
    Report Date
    April 11, 2025
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWR
    UDI-DI
    08022057015389
    PMA / PMN Number
    P150011S013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: THE DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. FDA PREMARKET SUBMISSION NUMBER OF SIMILAR DEVICE IS P150011 (SUPPLEMENT NUMBER 013); PRIMARY DI NUMBER FOR SIMILAR DEVICE IS 00896208000818. 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.

    Additional Manufacturer Narrative · 0

    SINCE THE DEVICE IS NOT ACCESSIBLE FOR TESTING, THE MANUFACTURER COULDN¿T PERFORM FURTHER INVESTIGATION ON THE PROSTHESIS INVOLVED IN THE REPORTED INCIDENT. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO DEFINITIVELY DETERMINE THE ROOT CAUSE OF THE AV BLOCK ONSET. HOWEVER, THE DOCUMENT REVIEW DID NOT IDENTIFY ANY MANUFACTURING DEFICIENCIES IN THE DEVICE. IT SHOULD BE NOTED THAT CONDUCTION DISORDERS ARE COMMON IN PATIENTS WITH AORTIC VALVE DISEASES, OFTEN LEADING TO THE NEED FOR PERMANENT PACEMAKER IMPLANTATION AFTER AORTIC VALVE REPLACEMENT. RISK FACTORS INCLUDE PREEXISTING CONDUCTION DISEASE, WHICH, AS CONFIRMED BY THE MANUFACTURER'S FOLLOW-UP, WAS NOT PRESENT THOUGH IN THE PATIENT'S MEDICAL HISTORY, AND PREOPERATIVE AORTIC REGURGITATION. THEREFORE, THE REPORTED EVENT IS A KNOWN INHERENT RISK OF THE PROCEDURE AND IS LISTED AMONG THE POTENTIAL ADVERSE EVENTS IN THE PERCIVAL IFU.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED THROUGH THE MANTRA STUDY OF A PATIENT WHO HAD A PERCEVAL SUTURELESS AORTIC BIOPROSTHESIS IMPLANTED AND RECEIVED A PERMANENT PACEMAKER TWO DAYS AFTER SURGERY. AS REPORTED, THE PATIENT DEVELOPED A THIRD-DEGREE AV BLOCK DESPITE HAVING NO PRE-EXISTING CONDUCTION DISTURBANCES. BASED ON THE AVAILABLE INFORMATION, THE PATIENT HAD A MEDICAL HISTORY OF DYSLIPIDEMIA, SYSTEMIC HYPERTENSION, CORONARY ARTERY DISEASE, STABLE ANGINA, MODERATE CHRONIC LUNG DISEASE, DIABETES MELLITUS TYPE II, INSULIN DEPENDENT AND HAD UNDERGONE PERCUTANEOUS CORONARY INTERVENTION WITH STENTING IN 2020. NYHA CLASS WAS ASSESSED AS II AT THE TIME OF SURGERY. THE SITE ASSESSED THE EVENT AS PROBABLY RELATED TO THE INITIAL IMPLANT PROCEDURE AND POSSIBLY RELATED TO THE DEVICE AND PRIMARY CONDITION BEING TREATED. THE MANUFACTURER IS FOLLOWING UP WITH THE SITE TO RETRIEVE ADDITIONAL INFORMATION REGARDING THE EVENT AND THE DEVICE INVOLVED. AS FURTHER REPORTED IN THE STUDY DATABASE, THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2024, DUE TO A NON-DEVICE-RELATED EVENT. THIS EVENT INVOLVED A STERNAL WOUND INFECTION, WHICH WAS TREATED WITH WOUND RE-EXPLORATION AND VAC THERAPY, AND WAS SUCCESSFULLY RESOLVED. THE SITE ASSESSED THIS EVENT AS DEFINITELY RELATED TO INITIAL PROCEDURE AND PRIMARY CONDITION BEING TREATED.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED THROUGH THE MANTRA STUDY OF A PATIENT WHO HAD A PERCIVAL SUTURELESS AORTIC BIOPROSTHESIS IMPLANTED AND RECEIVED A PERMANENT PACEMAKER TWO DAYS AFTER SURGERY. AS REPORTED, THE PATIENT DEVELOPED A THIRD-DEGREE AV BLOCK DESPITE HAVING NO PRE-EXISTING CONDUCTION DISTURBANCES. CABG (2 VESSELS) WAS PERFORMED AS CONCOMITANT PROCEDURE BEFORE VALVE TREATMENT. BASED ON THE AVAILABLE INFORMATION, THE PATIENT HAD A MEDICAL HISTORY OF DYSLIPIDEMIA, SYSTEMIC HYPERTENSION, CORONARY ARTERY DISEASE, STABLE ANGINA, MODERATE CHRONIC LUNG DISEASE, DIABETES MELLITUS TYPE II, INSULIN DEPENDENT AND HAD UNDERGONE PERCUTANEOUS CORONARY INTERVENTION WITH STENTING IN 2020. NYHA CLASS WAS ASSESSED AS II AT THE TIME OF SURGERY. THE SITE ASSESSED THE EVENT AS PROBABLY RELATED TO THE INITIAL IMPLANT PROCEDURE AND POSSIBLY RELATED TO THE DEVICE AND PRIMARY CONDITION BEING TREATED. THE MANUFACTURER IS FOLLOWING UP WITH THE SITE TO RETRIEVE ADDITIONAL INFORMATION REGARDING THE EVENT AND THE DEVICE INVOLVED. AS FURTHER REPORTED IN THE STUDY DATABASE, THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2024, DUE TO A NON-DEVICE-RELATED EVENT. THIS EVENT INVOLVED A STERNAL WOUND INFECTION, WHICH WAS TREATED WITH WOUND RE-EXPLORATION AND VAC THERAPY, AND WAS SUCCESSFULLY RESOLVED. THE SITE ASSESSED THIS EVENT AS DEFINITELY RELATED TO INITIAL PROCEDURE AND PRIMARY CONDITION BEING TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095707 PERCEVAL PLUS SUTRUELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR CORCYM S.R.L. PVF-L 08022057015389

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention