BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 7423826 · Received April 11, 2018

    Report

    Report Number
    3004478276-2018-00168
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    March 1, 2018
    Report Date
    May 25, 2018
    Manufacturer
    LIVANOVA CANADA CORP
    Product Code
    LWR
    UDI-DI
    00896208000443
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING AND MATERIAL RECORDS FOR THE PERCEVAL HEART VALVE, MODEL #ICV1211 , S/N # (B)(4), AS THEY PERTAIN TO THE REPORTED EVENT, WERE RETRIEVED AND REVIEWED BY QUALITY ENGINEERING AT LIVANOVA CANADA CORP. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A (MODEL #ICV1211) PERCEVAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE.

    Additional Manufacturer Narrative · 0

    HISTOLOGICAL ANALYSIS CONFIRMED THE PRESENCE OF MASSIVE THROMBUS DEPOSITION ON THE RETURNED VALVE. INFLAMMATORY CELLS WERE IDENTIFIED IN THE DEPOSITED THROMBUS. THERE WAS NO EVIDENCE OF ENDOCARDITIS. REVIEW OF THE STEADY FLOW TEST INSPECTION, THE PRINCIPAL DEVICE FUNCTIONAL TEST PERFORMED PRIOR TO RELEASE, CONFIRMED THAT THE VALVE MET THE ACCEPTANCE CRITERIA FOR A PERCEVAL PVS27. NO ANOMALIES WERE OBSERVED DURING THE OPEN/CLOSE CYCLE. BASED ON THE INFORMATION AVAILABLE IN THE EVENT DESCRIPTION, THE PATIENT'S MEDICAL HISTORY AND INR WERE INDICATIVE OF COAGULOPATHY. FURTHERMORE, THE PATIENT HAD SEVERAL RISK FACTORS (MODERATE MITRAL VALVE REGURGITATION, HYPERTENSION, CAROTID ARTERY DISEASE, DIABETES, KIDNEY FAILURE) THAT LIKELY CONTRIBUTED TO THE EVENT. AS REPORTED IN THE PERCEVAL IFU: "THE RISKS OR POTENTIAL ADVERSE EVENTS (IN ALPHABETICAL ORDER) ASSOCIATED WITH CARDIAC VALVE REPLACEMENT WITH A BIOPROSTHESIS INCLUDE, BUT MAY NOT BE LIMITED TO: ANGINA, CARDIAC ARRHYTHMIA, ... PROSTHESIS THROMBOSIS ..." AS SUCH, THE EVENT IS A KNOWN, INHERENT RISK OF THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED IN THE OPERATION REPORT INDICATES THAT THE PATIENT'S INR WAS LOW, AND THE PATIENT WAS THEREFORE SUSCEPTIBLE TO THROMBOSIS DUE TO COAGULOPATHY. THE PATIENT ALSO HAD A PREVIOUS THROMBOTIC EVENT IN 1995, SUGGESTING PRIOR COAGULOPATHY. THE PROSTHESIS WAS RECEIVED FOR ANALYSIS ON (B)(6) 2018. THE PROSTHESIS WAS RECEIVED IN POOR CONDITION. THE JAR IN WHICH THE VALVE WAS RECEIVED WAS TOO SMALL FOR THE VALVE. THE VALVE SHOWED NOTICEABLE THROMBUS ON THE OUTFLOW SIDE AND TWO LEAFLETS APPEARED TO BE DAMAGED. INVESTIGATION OF THE VALVE IS ONGOING. THE RESULTS WILL BE PROVIDED WITH THE FINAL REPORT.

    Description of Event or Problem · 1

    A PERCIVAL VALVE WAS IMPLANTED VIA FULL STERNOTOMY ON (B)(6) 2018. THE OPERATIVE COURSE WAS UNEVENTFUL. AFTER 7 DAYS, TEE REVEALED RESTRICTED MOTION OF THE RIGHT AND LEFT LEAFLETS DUE TO THROMBOTIC FORMATIONS. A REDO AVR WAS PERFORMED ON (B)(6) 2018 WHICH CONFIRMED THE DIAGNOSIS. THE VALVE WAS REPLACED WITH A 25 MM TRIFECTA VALVE WITH UNEVENTFUL CLINICAL COURSE FOLLOWING THE REOPERATION. IN THE OPERATION REPORTED PROVIDED, IT WAS INDICATED THAT THE PATIENT HAD COAGULOPATHY. FOLLOWING IMPLANT OF THE TRIFECTA VALE, ANTICOAGULATION THERAPY WAS ADMINISTERED. IT WAS INDICATED THAT THE TREATMENT SHOULD BE MAINTAINED UNTIL THE PATIENT'S INR REACHED 2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264065 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR LIVANOVA CANADA CORP PVS27 00896208000443

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R