BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3103648 · Received May 9, 2013

    Report

    Report Number
    2015691-2013-20048
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN EXPLANTED AND NO INFORMATION TO SUGGEST REOPERATION IS SCHEDULED. WITHOUT RETURN OF THE DEVICE AND EVALUATION, THE REPORTED CALCIFICATION CANNOT BE CONFIRMED OR EVALUATED. EDWARDS WILL CONTINUE TO FOLLOW UP WITH THE HEALTHCARE PROVIDER FOR ADDITIONAL INFORMATION AND RETURN OF DEVICE IF/WHEN EXPLANTED. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. ADDITIONAL INFORMATION WILL BE REPORTED IF PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT PHONE CALL THAT AN EDWARDS 3300TFX23MM BIOPROSTHETIC VALVE IS CALCIFYING AFTER A PERIOD OF 16 MONTHS. DEVICE REMAINS IMPLANTED. EDWARDS OBTAINED PATIENT DOCUMENTS FROM THE HOSPITAL; CATH LAB REPORT DATED (B)(6) 2013 (14 MONTHS POST IMPLANT) INDICATES: BIOPROSTHESIS NOTED IN THE AORTIC POSITION...NO REGURGITATION IDENTIFIED. MODERATE STENOSIS IS PRESENT. THE LEAFLETS ARE HEAVILY CALCIFIED. NO OBVIOUS VEGETATIVE MATERIAL IS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202645 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE 3300TFX23MM S-11H3028

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R