BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 4960486 · Received August 3, 2015

    Report

    Report Number
    2015691-2015-01927
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    June 25, 2015
    Report Date
    July 13, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUTURE LOOPING MAY OCCUR DURING A MITRAL VALVE REPLACEMENT DUE TO A SURGEON INADVERTENTLY LOOPING A SUTURE OVER ONE OF THE COMMISSURAL POSTS. THIS IS NOT A RESULT OF PRODUCT MALFUNCTION; HOWEVER, THIS MAY RESULT IN MILD TO SEVERE REGURGITATION AND IF UNDETECTED. FOR THIS CASE, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS BECAUSE IT WAS DISCARDED AT THE HOSPITAL. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    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, EDWARDS RECEIVED INFORMATION THAT THIS MITRAL PERICARDIAL VALVE WAS EXPLANTED AFTER FIFTEEN (15) DAYS DUE TO SUTURE LOOPING. THIS WAS REPLACED WITH A 27 MM PERICARDIAL BIOPROSTHESIS. NO ADDITIONAL DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504841 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R