BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2032138 · Received March 28, 2011

    Report

    Report Number
    2015691-2011-15110
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    December 8, 2010
    Report Date
    February 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - AV GROOVE TEAR. DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. DUE TO PATIENT PRIVACY REGULATIONS, NO ADDITIONAL INFORMATION (I.E. OPERATIVE REPORT, DISCHARGE SUMMARY, ETC.) COULD BE OBTAINED FROM THE HEALTH-CARE PROVIDER. THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROCESS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED, AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO QUALITY DEFICIENCY DETECTED.

    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 REPORTED THAT THE DEVICE WAS EXPLANTED ON THE SAME DAY OF SURGERY. ACCORDING TO THE SURGEON, THE DEVICE WAS EXPLANTED DUE TO AN "AV GROOVE TEAR." UNFORTUNATELY, NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX R-10H2112

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention