BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2830964 · Received November 14, 2012

    Report

    Report Number
    2015691-2012-18647
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 15, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROGRESS. THROUGH FOLLOW UP WITH THE CUSTOMER, IT WAS LEARNED THE VALVE WILL NOT BE RETURNED FOR EVALUATION DUE TO THE POSSIBLE INFECTION. IT WAS UNKNOWN WHETHER PATHOLOGY TEST WILL BE PERFORMED IN THE HOSPITAL. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. IN THIS CASE, THE SOURCE AND TYPE OF INFECTION WERE UNKNOWN.

    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, A 25MM VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY (B)(6) DUE TO MITRAL STENOSIS (MS). THROUGH FOLLOW UP, IT WAS LEARNED THAT ON (B)(6) 2012, THE VALVE WAS EXPLANTED AND REPLACED WITH A MAGNA MITRAL EASE VALVE, MODEL 7300TFX25MM. ON PREOPERATIVE DIAGNOSIS, C-REACTIVE PROTEIN (CRP) LEVEL WAS NORMAL AND IT DID NOT SHOW AN INFLAMMATION REACTION. HOWEVER MRI EXAMINATION SHOWED BLACK DOT IN THE BRAIN WHICH WAS MINUTE CEREBRAL INFARCTION (CI). THE CUSTOMER COMMENTED THAT INFECTIOUS ENDOCARDITIS (IE) WAS SUSPECTED AND CI MIGHT BE CAUSED BY THE VEGETATION. AT EXPLANT, DEGENERATION, WHICH SEEMED TO BE VEGETATION, WAS OBSERVED ON TWO OF THE LEAFLETS. THIS DEGENERATION RESTRICTED MOBILITY IN THE LEAFLETS.

    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 10A008

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R