BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 3203279 · Received July 2, 2013

    Report

    Report Number
    2015691-2013-20520
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE IS EXPECTED TO BE RETURNED TO EDWARDS; HOWEVER, IT HAS NOT YET BEEN RECEIVED OR EVALUATED. DEVICE EVALUATION RESULTS AND CONCLUSIONS WILL BE REPORTED ONCE AVAILABLE.

    Additional Manufacturer Narrative · 1

    X-RAY. DEVICE EVALUATION: AS RECEIVED, ALL 3 LEAFLETS HAD VEGETATION IN THE CUSP AREAS ON THE OUTFLOW AND INFLOW ASPECT. OBSERVATIONS ARE CONSISTENT WITH INFECTION AS DESCRIBED IN CUSTOMER REPORT. MINIMAL TO MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 5MM. MODERATE TO HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 7MM. HOST TISSUE WAS MINIMAL AT THE STENT INFLOW AND HEAVY AT THE STENT OUTFLOW. VEGETATION AND HOST TISSUE RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. SEWING RING WAS CUT BETWEEN COMMISSURE 2 AND COMMISSURE 3. THE X-RAY DEMONSTRATED NO VISIBLE DAMAGE TO WIREFORM. 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 PATIENT IS A KNOWN LONG TERM INTRAVENOUS DRUG ABUSER. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SALES FROM A SURGEON THAT AN EDWARDS BIOPROSTHETIC VALVE WAS EXPLANTED FROM THE TRICUSPID POSITION DUE TO ENDOCARDITIS AFTER AN IMPLANT DURATION OF APPROXIMATELY 2.5 YEARS. PATIENT NOTED AS AN IV DRUG USER. RECORDS INDICATE, " THE PATIENT IS A (B)(6) FEMALE WITH LONG HISTORY OF HEROIN ABUSE PRIMARILY INJECTING INTO HER SKIN. SHE HAS HAD MULTIPLE INFECTIONS. I REPLACED HER TRICUSPID VALVE SEVERAL YEARS AGO AND ALSO PLACED EPICARDIAL PACING LEADS, AND A PACEMAKER GENERATOR WAS PLACED BY THE ELECTROPHYSIOLOGY SERVICE AS SHE HAD COMPLETE HEART BLOCK AFTER HER SURGERY. SHE HAD A LONG HOSPITALIZATION, ULTIMATELY WAS DISCHARGED BUT CONTINUED TO USE HEROIN, PRESENTED BACK SEVERAL MONTHS AGO WITH PROSTHETIC VALVE ENDOCARDITIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302377 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R