BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLO SMART STENTLESS HEART VALVE

    MDR report key: 7100507 · Received December 8, 2017

    Report

    Report Number
    3004478276-2017-00212
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    March 4, 2017
    Report Date
    December 8, 2017
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000474
    PMA / PMN Number
    P130011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED TO THE MANUFACTURER THROUGH THE (B)(6) CLINICAL REGISTRY. THE SITE REPORTED AS UNKNOWN DEVICE RELATION. THE MANUFACTURER REQUESTED THE INTERNAL CLINICAL REVIEW OF THE EVENT WHICH DETERMINED AS UNKNOWN DEVICE RELATION. 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 EXPLANTED.

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED TO THE MANUFACTURER THROUGH THE (B)(6) CLINICAL REGISTRY: A SOLO SMART SIZE 23 WAS IMPLANTED ON (B)(6) 2016 VIA MINI- STERNOTOMY. THE VALVE WAS IMPLANTED SUPRA-ANNULAR. ON (B)(6) 2017, THE PATIENT EXHIBITED STROKE AND IT WAS REPORTED BY THE SITE AS UNKNOWN FOR DEVICE RELATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879504 SOLO SMART STENTLESS HEART VALVE TISSUE HEART VALVES LWR LIVANOVA CANADA CORP. ART23SMT 00896208000474

    Patients

    Seq Age Sex Outcome Treatment
    1 Other