BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 7102178 · Received December 8, 2017

    Report

    Report Number
    3004478276-2017-00214
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    February 1, 2017
    Report Date
    December 8, 2017
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000412
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER THE PERCEVAL IFU, STROKE IS A KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CARDIAC VALVE REPLACEMENT WITH A BIOPROSTHESIS. AS REPORTED IN THE SCIENTIFIC LITERATURE "STROKE IS A DEVASTATING COMPLICATION THAT MAY OCCUR EARLY OR LATE AFTER OPERATION IN PATIENTS WITH PROSTHETIC HEART VALVES AND RESULT FROM EMBOLISM, INTRACRANIAL HEMORRHAGE, OR BOTH ALTHOUGH INTRACRANIAL HEMORRHAGE IS A RELATIVELY RARE EVENT EXCEPT IN ELDERLY ANTICOAGULATED PATIENTS, AN EMBOLIC STROKE MAY OCCUR IN VIRTUALLY ANY PATIENT AND WITH ANY TYPE OF VALVE PROSTHESIS. RISK FACTORS FOR STROKE IN THE GENERAL POPULATION INCLUDE ADVANCED AGE, ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE, CONGESTIVE HEART FAILURE, MITRAL ANNULAR CALCIFICATION, HYPERTENSION, DIABETES, AND SMOKING. IN PATIENTS WITH PROSTHETIC HEART VALVES, THESE AND OTHER PATIENT-RELATED CHARACTERISTICS COULD INTERPLAY WITH THE DESIGN OF THE PROSTHESIS, THE SITE OF IMPLANTATION, AND THE ADEQUATENESS OF ANTICOAGULATION." RUEL, MARC, ET AL. "LATE INCIDENCE AND DETERMINANTS OF STROKE AFTER AORTIC AND MITRAL VALVE REPLACEMENT." THE ANNALS OF THORACIC SURGERY 78.1 (2004): 77-83. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE FOLLOWING EVENT WAS REPORTED TO THE MANUFACTURER THROUGH THE (B)(6) CLINICAL REGISTRY: A PERCEVAL SIZE 21 MM WAS IMPLANTED ON (B)(6) 2014 VIA MINI-THORACOTOMY. POST-DILATATION BALLOONING WAS DONE. ON (B)(6) 2017, THE PATIENT EXHIBITED A STROKE. THIS WAS REPORTED BY THE SITE AS UNKNOWN FOR DEVICE RELATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880434 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVES LWR LIVANOVA CANADA CORP. PVS21 00896208000412

    Patients

    Seq Age Sex Outcome Treatment
    1 Other