BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 5429595 · Received February 10, 2016

    Report

    Report Number
    3004478276-2016-00003
    Event Type
    Injury
    Date Received
    February 10, 2016
    Date of Event
    January 11, 2016
    Report Date
    January 11, 2016
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    DYE
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS THE PROCESS TO OBTAIN THE RETURN OF THE DEVICE. SINCE NO SERIAL NUMBER WAS PROVIDED FROM THE CUSTOMER, AT THIS TIME THE MANUFACTURER FACILITY IS UNKNOWN. THE PERCEVAL VALVES FOR THE EUROPEAN MARKET ARE MANUFACTURED IN TWO FACILITIES: LIVANOVA SORIN GROUP (B)(4). LIVANOVA CANADA CORP. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON 11 JAN 2016 THAT A FEMALE PATIENT, FIRST IMPLANTED WITH AN ENABLE IN (B)(6) 2015. INTRAOPERATIVELY ENABLE DID NOT STAY IN POSITION, AS THE AORTIC ANNULUS WAS NOT TRULY SYMMETRIC. THE SURGEON DECIDED TO SWITCH TO A PERCEVAL, WHICH COULD BE POSITIONED EASILY AND SHOWED GOOD GRADIENTS. FIVE MONTH AFTER IMPLANT, THE PATIENT CAME BACK WITH SEVERE SYMPTOMS. THE MEDICAL CHECK SHOWED THROMBUS ON ALL TREE LEAFLETS AND A RE-OPERATION WAS DONE TO CHANGE TO A STENTED VALVE. AFTER A FOLLOW-UP WITH THE SURGEON, THE MANUFACTURER RECEIVED THE FOLLOWING INFORMATION: FEMALE PATIENT, (B)(6), SEVERE AORTIC STENOSIS (PPG 72 MMHG, MPG 47 MMHG, AVA 0.5 CM2) MINIMALLY INVASIVE RIGHT ANTERIOR THORACOTOMY SAVR WITH PERCEVAL POSTOPERATIVE ECHOCARDIOGRAPHY AFER PERCEVAL: PPG OF 26 MMHG AND NO PERIVALVULAR LEAK (PVL). A PERMANENT PACEMAKER WAS IMPLANTED IN THE POSTOPERATIVE COURSE FOR SINUS BRADYCARDIA. ANTICOAGULATION PROTOCOL AFTER BIOLOGICAL AVR WAS FOLLOWED (INCLUDING LOW MOLECULAR WEIGHT HEPARIN ALONG WITH 100MG OF ACETYLSALICYLIC ACID ONCE DAILY LIFELONG AND 75 MG OF CLOPIDOGREL ONCE DAILY FOR 6 WEEKS). AFTER FULL MOBILIZATION LOW MOLECULAR WEIGHT HEPARIN WAS DISCONTINUED. XX MONTHS (NOT EXACTLY KNOWN TILL KNOW - WAITING FOR THE MEDICAL REPORT OF THAT CENTER) AFTER THE SAVR SHE PRESENTED TO HER LOCAL HEALTH PRACTITIONER WITH CHRONIC BACK PAIN AND RECEIVED A HIGH DOSE CORTISONE THERAPY. SHORTLY THEREAFTER SHE DEVELOPED PROGRESSIVE SHORTNESS OF BREATH ON EXERCISE. LABORATORY TESTS: NO SIGNS OF INFLAMMATION. ECHO: THROMBUS FORMATION WITHIN THE RIGHT AND NON CORONARY SINUS LEADING TO LEAFLET IMMOBILITY AND ELEVATED TRANSVALVULAR GRADIENT. CONTRAST ENHANCED COMPUTER TOMOGRAPHY VALIDATED THE THROMBUS FORMATION REDO: THE PROSTHESIS WAS PARTIALLY INCORPORATED INTO THE AORTIC ROOT BUT COULD BE REMOVED WITHOUT COLLATERAL DAMAGE. VALVE SUBSTITUTE: EDWARDS PERIMOUNT SIZE 21 WITH POSTOPERATIVE ECHOCARDIOGRAPHY: PPG 15 MMHG, NO LEAK HISTOLOGICAL EXAMINATION REVEALED THROMBOTIC MATERIAL FREE FROM INFLAMMATION. NO BACTERIAL CONTAMINATION COULD BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85981 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE DYE LIVANOVA CANADA CORP. PVS23

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention