BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 2032123 · Received March 28, 2011

    Report

    Report Number
    2015691-2011-15111
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    August 27, 2010
    Report Date
    February 26, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - AV GROOVE DISRUPTION. DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    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 DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 1 MONTH. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, ADDITIONAL INFORMATION WAS RECEIVED. ACCORDING TO THE OPERATIVE REPORT, THERE WAS A CONTAINED RUPTURE AND PSEUDOANEURYSM IN THE LEFT PERICARDIAL SPACE CONSISTENT WITH THE PREOPERATIVE CAT SCAN WITH BLOOD EMANATING FROM A DISRUPTED AV GROOVE. OF NOTE, THE MITRAL ANNULUS WAS QUITE FRIABLE. THE VALVE WAS EXPLANTED; THE AV GROOVE WAS DEBRIDED AND REPAIRED WITH A PATCH. A NEW EDWARDS BIOPROSTHETIC VALVE WAS IMPLANTED. PER THE SURGEON, THE REASON FOR REMOVING THE VALVE WAS NOT RELATED TO A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX R-10A0101

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention