BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL PLUS SUTRUELESS AORTIC HEART VALVE

    MDR report key: 21134127 · Received January 12, 2025

    Report

    Report Number
    3005687633-2025-00097
    Event Type
    Injury
    Date Received
    January 12, 2025
    Date of Event
    December 13, 2024
    Report Date
    February 20, 2025
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWR
    UDI-DI
    08022057015365
    PMA / PMN Number
    P150011/S013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, D9, G3, G6, H2, H3, H6, H11 THE DEVICE INVOLVED IN THIS EVENT IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. FDA PREMARKET SUBMISSION NUMBER FOR SIMILAR DEVICE: P150011/SUPPLEMENT NUMBER 013; PRIMARY DI NUMBER (B)(4). 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 DEVICE INVOLVED IN THE REPORTED EVENT WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND WAS RECEIVED IN A PLASTIC JAR FILLED WITH AN UNKNOWN LIQUID IN GOOD STORAGE CONDITIONS. AFTER DECONTAMINATION, THE VALVE WAS VISUALLY INSPECTED WITHOUT OBSERVING ANY MACROSCOPIC ANOMALIES AND/OR PRE-EXISTING DEFECTS ACCORDING TO THE SPECIFICATIONS. A DIMENSIONAL ANALYSIS WAS PERFORMED WITH THE DEDICATED GAUGE, WHICH CONFIRMED THE CORRECT DIMENSIONS OF THE RETURNED DEVICE. IN ORDER TO ATTEMPT TO REPRODUCE THE REPORTED EVENT, A REPLICATION OF COLLAPSING PHASES WAS PERFORMED USING THE RETURNED PVF-S PROSTHESIS AND A DEMO ACCESSORY KIT. NO PROBLEMS WERE ENCOUNTERED IN THE COLLAPSING PHASE, AND THE REPLICATION HAS BEEN COMPLETED WITH A GOOD RESULT. DURING THE SIMULATION OF VALVE DEPLOYMENT IN A SILICON AORTIC ROOT SIZE 21, NO PROBLEMS WAS ENCOUNTERED DURING THE BALLOONING PHASE: THE SEALING AT THE ANNULUS LEVEL WAS GUARANTEED AND THE VALVE REMAINED FIXED WITHIN THE ANNULUS. THEN, INSERTING SOME WATER IN THE AORTIC ROOT FROM THE OUTFLOW SIDE, NO PARAVALVULAR LEAKS WERE OBSERVED. CONSIDERING THE STATIC CONDITIONS OF THE TEST, THE WATER LEVEL REMAINED STABLE UNDER THE LEAFLETS FREE EDGE. BASED ON THE RESULTS OF THE ANALYSIS PERFORMED, THE REPORTED EVENT CANNOT BE EXPLAINED BY ANY FACTOR INTRINSIC IN THE INVOLVED DEVICE. THE MANUFACTURER IS FURTHER FOLLOWING UP WITH THE HEALTHCARE FACILITY IN AN ATTEMPT TO RETRIEVE FURTHER INFORMATION WHICH COULD BE RELEVANT TO ESTABLISH THE MOST REASONABLE ROOT CAUSE OF THE EVENT. A FOLLOW UP REPORT WILL BE SUBMITTED IN CASE ANY NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED OF AN INTRAOPERATIVE EXPLANT OF A PERCEVAL PLUS VALVE PVF-S OCCURRED ON (B)(6) 2024 DURING AN ISOLATED AVR SURGERY. REPORTEDLY, THE VALVE SIZE WAS SELECTED BASED ON PATIENT¿S ANNULUS SIZE, WHICH HAD BEEN DETERMINED THROUGH PRE-OPERATIVE CT SCAN PERFORMED BY THE HOSPITAL FACILITY. PATIENT¿S NATIVE VALVE WAS BICUSPID, STENOTIC WITH NO ABNORMAL GEOMETRIES IN THE ANNULUS. BASED ON THE INFORMATION RECEIVED, AFTER IMPLANT AND UPON ECHO CONFIRMATION, SEVERE PVL WAS OBSERVED, THEREFORE THE PERCEVAL VALVE WAS EXPLANTED, AND THE SURGERY WAS COMPLETED USING A CONVENTIONAL VALVE FROM A DIFFERENT MANUFACTURER (EDWARDS LIFESCIENCES INSPIRIS RESILIA). IT WAS REPORTED THAT NO DIFFICULTIES WERE ENCOUNTERED DURING THE COLLAPSING AND POSITIONING OF THE PERCEVAL VALVE. APPROXIMATELY 20 MINUTES WERE ADDED TO THE CROSS-CLAMP AND BYPASS TIME BECAUSE OF THE EVENT. AS REPORTED THE PATIENT WAS RELATIVELY STABLE THROUGHOUT THE SURGERY WHICH WAS COMPLETED WITHOUT COMPLICATIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2024 DURING AN AVR SURGERY, A PERCEVAL PLUS VALVE PVF-S WAS DECIDED TO BE AN APPROPRIATE SIZE USING ANNULUS SIZE. HOWEVER, AFTER IMPLANT AND UPON ECHO CONFIRMATION, SEVERE PVL WAS OBSERVED. THE IMPLANTED VALVE WAS EXPLANTED, AND THE SURGERY WAS COMPLETED USING A CONVENTIONAL VALVE FROM ANOTHER COMPANY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498246 PERCEVAL PLUS SUTRUELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR CORCYM S.R.L. PVF-S 08022057015365

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention