BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2183381 · Received July 28, 2011

    Report

    Report Number
    2015691-2011-15967
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 30, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = VEGETATIONS. ADDITIONAL MANUFACTURER NARRATIVE: THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS LEARNED THAT THE DEVICE WAS REMOVED DUE TO PROSTHETIC AORTIC VALVE ENDOCARDITIS WITH VEGETATIONS. THE ABSCESS WAS IN THE ROOT OF THE AORTA ONTO THE VENTRICLE. THE SURGEON RESECTED THE ABSCESS, ALL THE NECROTIC MATERIAL, REMOVED THE OLD VALVE, LYSIS OF ADHESIONS, BUT THE REGION WAS FOUND TO BE VERY NECROTIC, PERIWOUND ABSCESS. THE VALVE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. ADDITIONALLY, THE SURGEON INDICATED THAT THIS EVENT WAS NOT RELATED TO A DEVICE MALFUNCTION. 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. OF NOTE, THIS PATIENT ALSO HAS ANOTHER RELATED EVENT; PLEASE REFERENCE THE OTHER MEDWATCH SUBMITTED UNDER DEVICE SERIAL # (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. DESPITE MULTIPLE ATTEMPTS, THE HEALTHCARE PROVIDER HAS NOT PROVIDED ANY ADDITIONAL INFORMATION REGARDING THIS EXPLANT; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED INTO THE ROOT CAUSE OF 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 EDWARDS' BIOPROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 77 MONTHS, AND REPLACED WITH ANOTHER EDWARDS' VALVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 3D0699

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R