BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 2132949 · Received June 17, 2011

    Report

    Report Number
    2015691-2011-15738
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    February 9, 2011
    Report Date
    May 20, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) VEGETATIONS ON PROSTHETIC VALVE. ADDITIONAL MANUFACTURER NARRATIVE: THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO PROSTHETIC MITRAL VALVE ENDOCARDITIS WITH SECONDARY MITRAL STENOSIS AND MITRAL REGURGITATION AND LARGE VEGETATIONS ON THE VALVE. (PER THE OPERATIVE REPORT) SUMMARY OF OPERATIVE FINDINGS: THE PATIENT WAS FOUND TO HAVE PULMONARY HYPERTENSION WITH PA PRESSURES OF 60/40. HER AORTA HAD NO SIGNIFICANT DISEASE IN THE ASCENDING AORTA. THE PATIENT HAD SIGNIFICANT ADHESIONS. HER TISSUES WERE VERY FRAGILE. THE RIGHT ATRIUM WAS THIN AND SLIGHTLY DILATED, GRADE 3/6. THE LEFT SIDE WAS QUITE ADHERED DOWN AND FORMAL DISSECTION WAS NOT PERFORMED. THE PATIENT HAD VEGETATIONS ON HER VALVE THAT WERE ON THE ANNULUS. ONE OF THE LEAFLETS WAS COVERED WITH VEGETATION, ONE OF THE LEAFLETS WAS TOTALLY CALCIFIED AND NON-COMPLIANT. THE VALVE WAS OBVIOUSLY INFECTED. THERE WAS NO OBVIOUS INFECTION IN THE WALL OF THE ATRIUM OR OUTSIDE OF THE MITRAL APPARATUS. THE LEFT ATRIUM WAS ENLARGED, GRADE 3/6. IT WAS THICKENED. NO OTHER ABNORMALITIES WERE IDENTIFIED. CONCLUSION: 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 THE INFECTION PROVIDED BY THE HEALTH-CARE PROVIDER WAS: DIALYSIS CATHETER.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. 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 REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 3 YEARS. THE REASON FOR EXPLANTING THE DEVICE WAS NOT PROVIDED. NO FURTHER DETAILS WERE REPORTED.

    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-07F1274

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R