BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE

    MDR report key: 21705913 · Received March 27, 2025

    Report

    Report Number
    3005687633-2025-00105
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    February 28, 2025
    Report Date
    May 7, 2025
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWR
    UDI-DI
    08022057015372
    PMA / PMN Number
    P150011S013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: THE DEVICE INVOLVED IN THE REPORTED EVENT IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. INFORMATION ON SIMILAR DEVICE IS REPORTED BELOW: PRIMARY DI NUMBER: (B)(4). FDA PREMARKET SUBMISSION NUMBER: P150011 SUPPLEMENT NUMBER: 013. 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 INVESTIGATION OF THE RETURNED DEVICE IS IN PROGRESS. IN ADDITION, THE MANUFACTURER IS ATTEMPTING TO RETRIEVE FURTHER INFORMATION ON THE REPORTED EVENT. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY NEW INFORMATION OR AT THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE PVF-M VALVE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND WAS RECEIVED IN A PLASTIC JAR FILLED WITH AN UNKNOWN LIQUID. THE PROSTHESIS APPEARED TO BE IN GENERALLY GOOD CONDITION, ALTHOUGH THE PERICARDIUM FELT SLIGHTLY FIRM UPON PALPATION. A DIMENSIONAL ANALYSIS WAS CONDUCTED TO ENSURE THE DEVICE MET THE SPECIFICATIONS. BOTH THE VALVE INFLOW SKIRT AND THE SINUSOIDAL STRUCTURES WERE FOUND TO BE COMPLIANT. TO ATTEMPT TO REPLICATE THE REPORTED EVENT, SIMULATIONS OF COLLAPSING, DEPLOYMENT AND BALLOONING PHASES WERE PERFORMED, ACCORDING TO THE INDICATION INCLUDED IN THE DEVICE IFU. IN PARTICULAR, THE DEPLOYMENT AND BALLOONING PHASES WERE PERFORMED IN SILICON AORTIC ROOTS OF THE EXTREME SIZES INDICATED FOR A PVF-M IMPLANT (SIZE 21 AND SIZE 23). NO PROBLEMS WERE ENCOUNTERED DURING THE DEPLOYMENT AND BALLOONING PHASES IN BOTH SIMULATIONS: THE SEALING AT THE ANNULUS LEVEL WAS GUARANTEED; THUS, THE VALVE REMAINED FIXED WITHIN THE ANNULUS. THEN, INSERTING WATER IN THE AORTIC ROOT FROM THE OUTFLOW SIDE, NO SEVERE PARAVALVULAR LEAKS WERE OBSERVED DURING BOTH SIMULATIONS. CONSIDERING THE STATIC CONDITIONS OF THE TEST, THE WATER LEVEL REMAINED STABLE UNDER THE LEAFLETS FREE EDGE. DESPITE THE NOT OPTIMAL MORPHOLOGICAL CONDITIONS OF THE DEVICE, THE DEPLOYMENT SIMULATIONS PERFORMED ON THE RETURNED VALVE, DID NOT HIGHLIGHT ANOMALIES AND THE VALVE RESULTED GLOBALLY WELL DEPLOYED AND FIXED IN STABLE WAY. NO SEVERE PARAVALVULAR LEAKS WERE OBSERVED DURING THE SIMULATIONS OF THE STATIC LEAK TEST AS FURTHER CONFIRMATION OF THE STABILITY OF THE POSITIONING AND SEALING PERFORMANCE. CONSIDERING THE RESULTS OF THE ANALYSES CARRIED OUT, IT IS POSSIBLE TO EXCLUDE THE RELATIONSHIP BETWEEN THE REPORTED ISSUE AND THE QUALITY OF THE RETURNED DEVICE, AS NO POSITIONING PROBLEMS OR NOTABLE EVIDENCE OF INSTABILITY OF THE PROSTHESIS, ONCE POSITIONED, WERE OBSERVED. BASED ON THE MANUFACTURER'S EXPERIENCE, THE MOST REASONABLE CAUSE OF THE OBSERVED SEVERE PVL MAY BE ASSOCIATED WITH ANATOMICAL ASPECTS OF THE IMPLANTATION SITE, EVEN IF THIS CANNOT ULTIMATELY BE CONFIRMED DUE TO THE PAUCITY OF INFORMATION PROVIDED TO THE MANUFACTURER DESPITE MULTIPLE ATTEMPTS TO FOLLOW UP. THE MANUFACTURER WILL SUBMIT A NEW FOLLOW-UP REPORT SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED IN THE FUTURE.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL PLUS SIZE M PROSTHESIS OCCURRED ON (B)(6) 2025 DURING AN AVR SURGERY. REPORTEDLY, BY USING THE ANNULUS SIZER IT WAS DETERMINED THAT SIZE M WAS APPROPRIATE. HOWEVER, UPON ECHO CONFIRMATION, SEVERE PVL WAS OBSERVED. THEREFORE, THE IMPLANTED PERCEVAL PROSTHESIS WAS EXPLANTED AND THE SURGERY WAS COMPLETED USING A CONVENTIONAL VALVE FROM A DIFFERENT MANUFACTURER, WITHOUT REPORTED COMPLICATIONS AND WITH GOOD PATIENT OUTCOME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603873 PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR CORCYM S.R.L. PVF-M 08022057015372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention