BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3830745 · Received May 23, 2014

    Report

    Report Number
    2015691-2014-01230
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    November 6, 2013
    Report Date
    April 24, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO OTHER DETAILS REPORTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE - REPORT OF EXPLANTED AORTIC BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. FOLLOW UP FOR FURTHER EVENT INFORMATION IS CURRENTLY UNDERWAY, ADDITIONAL INFORMATION WILL BE REPORTED IF RECEIVED. WITHOUT ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER AND/OR DEVICE EVALUATION, THE ROOT CAUSE OF THIS EVENT CANNOT BE IDENTIFIED OR EVALUATED. EDWARDS WILL CONTINUE TO MONITOR ALL EVENTS.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL ¿CUSTOMER COMPLAINT.¿ THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS AND 9 MONTHS. THE REASON FOR EXPLANT IS UNKNOWN. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER PROSTHETIC VALVE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS WAS THE SECOND EXPLANT FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308899 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 09K263

    Patients

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