BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 2210825 · Received August 12, 2011

    Report

    Report Number
    2015691-2011-16036
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 15, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - VEGETATION AND ABSCESS. EVALUATION METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE SUBJECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AND ANALYSIS; 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 OF INFECTION IS UNKNOWN. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE 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 MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 9 MONTHS. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO BACTERIAL ENDOCARDITIS IN THE PROSTHETIC VALVE, GM+ COCCI - STAPHYLOCOCCUS EPIDERMIDIS. OPERATIVE REPORT INDICATES, "THE PATIENT DID WELL UNTIL ABOUT 3 WEEKS AGO WHEN HE WAS NOTED TO HAVE SEVERE BACK PAIN. FURTHER EVALUATION DEMONSTRATED A SPINAL INFECTION, POSSIBLE ABSCESS. THE PATIENT HAD STAPH EPI BACTEREMIA. SUBSEQUENT TEE DEMONSTRATED INSTABILITY OF THE MITRAL VALVE PROSTHESIS ALONG THE FIBROUS TRIGONE IN THE AREA OF THE ANTEROLATERAL MITRAL COMMISSURE...PATIENT HAD NO EVIDENCE OF MITRAL REGURGITATION DESPITE EVIDENCE OF ENDOCARDITIS. THE PATIENT UNDERWENT CORONARY ANGIOGRAM WHICH DEMONSTRATED A PATENT GRAFT WITH LEFT INTERNAL MAMMARY ARTERY. FOR THIS REASON, THE PATIENT IS REFERRED FOR REDO STERNOTOMY AND MITRAL VALVE REPLACEMENT...WHILE MITRAL VALVE COMPLETELY EXPOSED, IT IS OBVIOUSLY THAT THIS IS A VEGETATION AND ABSCESS AREA ALONG THE P1 AREA OF THE MITRAL ANNULUS JUST BELOW THE ANTEROLATERAL COMMISSURE...ALL THE INFECTED TISSUE WAS DEBRIDED OFF THE MITRAL ANNULUS, AWAY FROM THE PAPILLARY MUSCLE".

    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-09H2014

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R