BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL S HEART VALVE

    MDR report key: 7100602 · Received December 8, 2017

    Report

    Report Number
    3005687633-2017-00130
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    December 11, 2015
    Report Date
    March 6, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    LWR
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED IN THE PERCEVAL IFU, STROKE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CARDIAC VALVE REPLACEMENT WITH A BIOPROSTHESIS: 'THE RISKS OR POTENTIAL ADVERSE EVENTS ... ASSOCIATED WITH CARDIAC VALVE REPLACEMENT WITH A BIOPROSTHESIS INCLUDE, BUT MAY NOT BE LIMITED TO: ARRHYTHMIAS, CARDIAC TAMPONADE, DEATH, ENDOCARDITIS, ... THROMBOEMBOLISM, TISSUE DEHISCENCE ...THE PREVIOUSLY MENTIONED ADVERSE EVENTS AND OTHER ADVERSE EVENTS MAY ARISE IN RESPONSE TO THE INDIVIDUAL PATIENT REACTIONS TO THE IMPLANTED PROSTHESIS." AS REPORTED BY RUEL ET AL, "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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT EXPERIENCED A SMALL STROKE POST-OPERATIVELY IN ICU. THE EVENT WAS NOT BELIEVED TO BE RELATED TO THE DEVICE IN ANY WAY, AND THE SURE-AVR PATIENT REGISTRY HAS SINCE BEEN UPDATED TO REFLECT THIS INFORMATION. THE STROKE WAS NON-DISABLING, AND THE PATIENT HAD SINUS RHYTHM AT THE TIME OF THE EVENT. BASED ON THE INFORMATION PROVIDED, THIS EVENT IS NOT VALVE-RELATED AND NO FURTHER INVESTIGATION IS NECESSARY.

    Description of Event or Problem · 1

    A PERCEVAL SIZE 27 WAS IMPLANTED ON (B)(6) 2015 VIA MINI-STERNOTOMY. ON (B)(6) 2015, THE PATIENT HAD A STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879833 PERCEVAL S HEART VALVE TISSUE HEART VALVES LWR SORIN GROUP ITALIA S.R.L. PVS27

    Patients

    Seq Age Sex Outcome Treatment
    1 Other