BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 3071586 · Received April 22, 2013

    Report

    Report Number
    2015691-2013-19881
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 17, 2013
    Report Date
    March 26, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER WAS PROVIDED. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    ATRIAL FIBRILLATION (AF) IS A COMMON ARRHYTHMIA IN PATIENTS UNDERGOING VALVE REPLACEMENT. IT IS A COMMON PRE-EXISTING CONDITION, CAN BE ASSOCIATED WITH THE PROCEDURE, OR CAN BE A PROGRESSION OF THE PATIENT'S DISEASE AT SOME POINT IN THE POST-OPERATIVE PERIOD. IT IS OFTEN TRANSIENT AND DOES NOT REQUIRE INTERVENTION. IN SOME CASES, IT CAN ADVERSELY AFFECT CARDIAC OUTPUT AND WILL REQUIRE INTERVENTION, PARTICULARLY IN PATIENTS WITH LIMITED CARDIAC RESERVE. ALTHOUGH A WELL-RECOGNIZED COMPLICATION OF HEART SURGERY, IT IS TYPICALLY NOT RELATED TO THE DEVICE, BUT THE PROCEDURE OR UNDERLYING CARDIAC DISEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINICAL AFFAIRS THAT A PATIENT EXPERIENCED RAPID ATRIAL FIBRILLATION (120-140), POST IMPLANTATION OF AN EDWARDS BIOPROSTHETIC AORTIC VALVE. PATIENT WAS GIVEN MEDICATION AND CARDIOVERTED TO TREAT THE EVENT. NO DEVICE MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171294 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 2700TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R