BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3031767 · Received April 2, 2013

    Report

    Report Number
    2015691-2013-19716
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED. 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. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONFIRMED. ALTHOUGH THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED, IT APPEARS THAT THIS EVENT MAY HAVE BEEN RELATED TO THE PATIENT'S LONG HISTORY OF VENOUS INSUFFICIENCY AND A CHRONIC ULCER ON THE LEFT LOWER LEG MEDIALLY. THE OP REPORT DOCUMENTS POSITIVE BLOOD CULTURES FOR STEP VIRIDANS. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION AT THIS TIME.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 YEARS DUE TO PROSTHETIC AORTIC VALVE ENDOCARDITIS. ACCORDING TO THE OP REPORT, THIS PATIENT HAS A LONG HISTORY OF VENOUS INSUFFICIENCY AND A CHRONIC ULCER ON THE LEFT LOWER LEG MEDIALLY. IN (B)(6), SHE DEVELOPED FEVERS AND WAS FOUND TO HAVE BLOOD CULTURES POSITIVE FOR STREP VIRIDANS WHICH LED TO A LONG COURSE OF IV ANTIBIOTICS. SHE WAS IN AND OUT OF THE HOSPITAL WITH A TEE DONE ON (B)(6) 2013 WHICH SHOWED MODERATE MITRAL REGURGITATION (MR) AND MILD AORTIC REGURGITATION (AR). CREATININE WAS 0.9 AT THAT TIME. SHE HAD BEEN READMITTED, NOW WITH A CREATININE OF 2.0 AND HEMOGLOBIN OF ONLY 7. REPEAT TEE SHOWED DEFINITE EVIDENCE OF A ROOT ABSCESS AND WORSE MR. THEREFORE, AORTIC VALVE AND ROOT REPLACEMENT AND MITRAL VALVE REPAIR WAS SCHEDULED. AT OPERATION, TEE CONFIRMED VEGETATIONS ON THE VENTRICULAR ASPECT OF THE BIOPROSTHETIC AORTIC VALVE AND EXTENSIVE ANNULAR DESTRUCTION IN THE AORTO-MITRAL CURTAIN WITH ROOT ABSCESS. THE PROSTHETIC AORTIC VALVE WAS EXTENSIVELY DEGENERATED WITH PARTICULATE MATTER ALL OVER THREE LEAFLETS. THERE WAS A SMALL CAVITY IN THE BACK UNDER THE LEFT MAIN TOWARD THE POSTERIOR COMMISSURE FROM WHICH EXUDED PUS WHEN THE ANNULUS WAS CUT AT THIS LEVEL. THE PATIENT'S AORTIC VALVE AND ROOT WAS REPLACED WITH A 24 MM AORTIC HOMOGRAFT CONDUIT. TEE AT THE END OF THE PROCEDURE REVEALED NORMAL VALVE FUNCTION AT ALL THREE LEVELS; THERE WAS NO AR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134555 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R