BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 2819533 · Received November 5, 2012

    Report

    Report Number
    2015691-2012-18605
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 10, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE SAMPLE DEVICE WAS NOT RETURNED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED. FOLLOW UP FOR ADDITIONAL INFORMATION IS CURRENTLY BEING MADE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT THAT ANY NEW INFORMATION OR SAMPLE DEVICE IS RECEIVED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, THE EXPLANT WAS DUE TO ENDOCARDITIS, SOURCE WAS LIKELY FUNGAL AND SEVERE MITRAL STENOSIS. THE HEALTH-CARE PROVIDER ALSO NOTED THAT THE EXPLANT WAS PATIENT RELATED AND NOT RELATED TO ANY DEVICE MALFUNCTION. PER THE OP REPORT, THE MITRAL VALVE WAS HEAVILY INVOLVED WITH VEGETATIONS AND WAS EXTREMELY TIGHT WITH ONE OF THE VEGETATIONS NEARLY OCCLUDING THE CENTRAL LUMEN. THE VALVE WAS ELEVATED AND REMOVED; THE ANNULUS WAS DEBRIDED. A 29 MM EDWARDS VALVE WAS SEATED; EXAMINATION OF THE VALVE REVEALED EXCELLENT COAPTATION OF THE VALVE LEAFLETS. UPON SEPARATION FROM CARDIOPULMONARY BYPASS, TRANSESOPHAGEAL ECHOCARDIOGRAPHIC EXAMINATION OF THE HEART REVEALED EXCELLENT FUNCTIONAL PROSTHETIC VALVE WITH GOOD VENTRICULAR FUNCTION AND NO AIR. THE PATIENT WAS TRANSFERRED ON SOME LOW-DOSE EPINEPHRINE AND LEVOPHED FROM THE OPERATING ROOM TO THE ICU. PER THE DISCHARGE SUMMARY, THE PATIENT HAD PREVIOUSLY UNDERGONE MITRAL VALVE REPLACEMENT IN 2008 FOR MRSA BACTEREMIA ASSOCIATED WITH MITRAL VALVE ENDOCARDITIS AND ENDOPHTHALMITIS OF THE LEFT EYE SECONDARY TO EMBOLIC PHENOMENA. POSTOPERATIVELY, THE PATIENT HAD SHOCK AND DID POORLY. HIS MITRAL VALVE VEGETATION DID END UP GROWING YEAST. HE HAD REFRACTORY SHOCK AND EXPIRED ON (B)(6) 2012. THERE ARE SEVERAL POTENTIAL CAUSES FOR PROSTHETIC VALVE STENOSIS (E.G. CALCIFICATION, PANNUS GROWTH). UNFORTUNATELY, THE SUBJECT DEVICE HAS BEEN DISCARDED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE INVESTIGATED. 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, PER THE DISCHARGE SUMMARY DISCHARGE DIAGNOSES, THE SOURCE OF ENDOCARDITIS WAS LIKELY FUNGAL. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 4 YEARS AND 2 MONTHS. UNFORTUNATELY, THE REASON FOR EXPLANT HAS NOT BEEN PROVIDED. NO OTHER DETAILS REPORTED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION OR QUALITY DEFICIENCY. THE SUBJECT DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R