BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 4252130 · Received November 14, 2014

    Report

    Report Number
    2015691-2014-02710
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 21, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    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. IN THIS CASE, EDWARDS RECEIVED INFORMATION THAT THIS AORTIC BIOPROSTHETIC HEART VALVE WAS EXPLANTED AFTER NINE (9) YEARS, TEN (10) MONTHS DUE TO STENOSIS. THIS WAS REPLACED WITH A 25MM PERICARDIAL BIOPROSTHESIS. POST-OPERATIVELY, THE AORTIC VALVE APPEARED TO BE FUNCTIONING NORMALLY WITH NO PERIVALVULAR LEAK AND NO EVIDENCE OF STENOSIS. THE PATIENT WAS TRANSFERRED BACK TO THE CORONARY CARE UNIT (CCU) AND DISCHARGED HOME ON POST-OPERATIVE DAY #6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737766 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R LOPRESSOR| ROSUVASTATIN| CRESTOR| ASPIRIN| WARFARIN| COQ10| AMIODARONE