BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 2091871 · Received May 17, 2011

    Report

    Report Number
    2015691-2011-15554
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 20, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S01
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE (B)(4) NO CODE AVAILABLE = LEAFLET DISRUPTION (TEARING AT THE COMMISSURE). EVALUATION (B)(4) - OTHER = DEVICE HAS NOT BEEN RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY REVIEW IS IN PROCESS. SEVERAL ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE OPERATIVE REPORT, HOWEVER, EDWARDS WAS INFORMED THAT THESE DOCUMENTS CANNOT BE RELEASED WITHOUT PATIENT AUTHORIZATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. ATTEMPTS TO OBTAIN THE SUBJECT DEVICE AND OPERATIVE REPORTS HAVE BEEN MADE, HOWEVER, IT WAS REPORTED THAT NO INFORMATION CAN BE RELEASED WITHOUT PATIENT AUTHORIZATION. AT THIS TIME, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MAGNA PERICARDIAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 6 YEARS DUE TO TEARING AT THE COMMISSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000 4D0584

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R