BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3945096 · Received July 18, 2014

    Report

    Report Number
    2015691-2014-01639
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 25, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROSTHETIC VALVE ENDOCARDITIS (PVE) IS AN ENDOVASCULAR, MICROBIAL INFECTION OCCURRING ON PARTS OF THE VALVE PROSTHESIS OR ON RECONSTRUCTED NATIVE HEART VALVES. LATE ENDOCARDITIS OCCURS DUE TO THE IMPLANT BEING SEEDED FROM AN INFECTION OR MICROBIAL CONTAMINATION FROM ELSEWHERE IN THE BODY AND IS NOT IN ANY WAY RELATED TO THE STERILIZATION OR PACKAGING PROCESS OF THE DEVICE. THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS BECAUSE IT WAS DISCARDED AT THE HOSPITAL. 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.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED ADDITIONAL MANUFACTURER NARRATIVE ALTHOUGH THERE HAVE BEEN ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION WAS RECEIVED AND THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS AORTIC BIOPROSTHETIC VALVE, IMPLANTED APPROXIMATELY THREE (3) MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. THIS WAS REPLACED WITH A 21 MM PERICARDIAL BIOPROSTHESIS. NO ADDITIONAL DETAILS PROVIDED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED ADDITIONAL INFORMATION INDICATING THE REASON FOR EXPLANT WAS DUE TO PROSTHETIC VALVE ENDOCARDITIS FROM AN UNKNOWN SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421885 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R