BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2103185 · Received May 25, 2011

    Report

    Report Number
    2015691-2011-15615
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    January 25, 2011
    Report Date
    April 27, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. DESPITE MULTIPLE FOLLOW-UP ATTEMPTS, THE HEALTHCARE PROVIDER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION SUCH AS REASON FOR EXPLANT, OPERATIVE REPORT, AND DEVICE STATUS DUE TO PATIENT PRIVACY REGULATIONS; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED INTO THE ROOT CAUSE OF THIS EVENT. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION, OR A QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    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, IT WAS LEARNED THAT THE EDWARDS' TRICUSPID VALVE PROSTHESIS WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 37 MONTHS, AND REPLACED BY ANOTHER EDWARDS' DEVICE. THE REASON FOR EXPLANTING HAS NOT BEEN PROVIDED BY THE HEALTHCARE PROVIDER DUE TO PATIENT PRIVACY REGULATIONS. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P R-07H1730

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R