BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BIOPROSTHESIS W/ THERMAFIX

    MDR report key: 1666258 · Received April 23, 2010

    Report

    Report Number
    2015691-2010-13201
    Event Type
    Death
    Date Received
    April 23, 2010
    Date of Event
    March 24, 2010
    Report Date
    March 24, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED VIA EMAIL FROM PATIENT. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THE 03/26/10 E-MAIL REQUEST TO SALES REPRESENTATIVE REQUESTING PATHOLOGY REPORT TO NO RESPONSE. ALSO, INCLUDED DEVICE RETURN INSTRUCTIONS.

    Additional Manufacturer Narrative · 1

    A MORE COMPLETE DESCRIPTION OF INVESTIGATION, EVALUATION, FAILURE ANALYSIS AND/OR LABORATORY TESTING, INCLUDING DATA ON SPECIFIC COMPONENTS INVOLVED, AS APPLICABLE, METHODOLOGY(IES) USED FOR ANALYSIS AND/OR TESTING, AND FOLLOW-UP EFFORTS TAKEN TO DATE. PLEASE INCLUDE A COPY OF ANY INVESTIGATION, EVALUATION, FAILURE ANALYSIS, AND/OR LABORATORY TESTING SUMMARY RELEVANT TO THE REPORTED EVENT. RESPONSE: EDWARDS PERFORMED A THOROUGH INVESTIGATION OF THE REPORTED DEVICE INCLUDING A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS, AND COMPLAINT DATABASE. OUR REVIEW HAS CONFIRMED THAT THIS DEVICE MET ALL SPECIFICATIONS PRIOR TO RELEASE. A SECONDARY INVESTIGATION WAS CONDUCTED TO IDENTIFY ALL DEVICES WITHIN THE MANUFACTURING AND STERILIZATION LOT RELATED TO THIS DEVICE. WE HAVE CONFIRMED THAT THERE ARE NO ADDITIONAL FIELD REPORTS AGAINST ANY ADDITIONAL VALVE FROM THESE LOTS. AN ADDITIONAL SEARCH OF OUR DATABASE AND COMPLAINT RECORDS WAS CONDUCTED FOR ANY OTHER REPORTED CASE OF INFECTION/ENDOCARDITIS INVOLVING A CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS WITHIN THE PAST TWO YEARS. NO OTHER SIMILAR EVENTS WERE FOUND. REQUESTS WERE SENT ON MARCH 26, 2010 AND APRIL 23, 2010 FOR PATHOLOGY AND AUTOPSY REPORTS, AND RETURN OF DEVICE. EMAIL RESPONSE STATED HOSPITAL WILL NOT RELEASE PATIENT INFORMATION. JUNE 09, 2010 RESPONSE THROUGH SALES REP, WE LEARNED FROM THE SURGEON THAT THE DEVICE WAS NEVER EXPLANTED FROM THE DECEASED AND IS NOT AVAILABLE FOR RETURN. 2) IF THE PATIENT OR DEVICE PROBLEMS (INCLUDING ANY FAILURE ANALYSES) NOTED IN THIS REPORT ARE PART OF A TREND ANALYSIS, PLEASE PROVIDE A COMPLETE LIST OF ALL RELATED MDR ACCESS NUMBERS, AS WELL AS THE BASIS FOR THEIR INCLUSION IN THE TREND, E.G. COMMON CLINICAL PRESENTATION/OBSERVATION, COMMON COMPONENT, COMMON MANUFACTURING PROCESS, KNOWN FAILURE MODE, ETC. RESPONSE: A REVIEW OF OUR 2007-2010 DATA REVEALED NO OTHER REPORTABLE EVENTS FOR THIS MODEL (3000TFX), WHERE THE PATIENT HAD BLOOD CULTURES POSITIVE FOR CANDIDA. THE PATIENT/DEVICE ISSUE REPORTED IS NOT CURRENTLY PART OF A TREND ANALYSIS. THE EVENT, LIKE ALL CUSTOMER EXPERIENCE REPORTS, IS INCLUDED IN OUR REGULAR MONITORING AND REVIEW OF CUSTOMER EXPERIENCE REPORT INFORMATION, BUT EVENTS WITH THIS DESCRIPTION OCCUR AT A FREQUENCY SO LOW AS TO PRECLUDE MEANINGFUL TRENDING AT THIS TIME. - (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED BY DR (B) (6) VIA E-MAIL TO SALES REPRESENTATIVE (B) (4), E-MAIL STATED THE FOLLOWING, ¿I DID A REDO STERNOTOMY (PRIOR CABG) AND PLACED AN AORTIC THERMAFIX VALVE IN A PATIENT ABOUT 3 WEEKS AGO ((B) (6) 2010). POSTOPERATIVELY THE PATIENT SPIKED ON THE SECOND DAY AND SHORTLY THEREAFTER HAD BLOOD CULTURES POSITIVE FOR CANDIDA. THIS IS QUITE UNUSUAL AS I WOULD HAVE EXPECTED A BACTERIAL CAUSE. HE WAS TREATED WITH ANTIFUNGALS BUT EVENTUALLY EXPIRED. WOULD YOU PLEASE CHECK AND SEE IF THERE WAS A CULTURE ISSUE WITH THE VALVE BATCH? I WAS TRYING TO LOCATE THE VALVE SERIAL NUMBER BUT SO FAR THE RECORDS ARE NOT FULLY SCANNED IN YET." PLEASE NOTE THAT THE AWARE DATE IS BEING USED AS THE OCCURRENCE DATE UNTIL DATE OF DEATH IS KNOWN. (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED REVIEW OF LEAD DATA REVEALED THE RV PACE IMPEDANCE WAS TYPICALLY IN THE 400 - 500 OHM RANGE. THERE WERE OCCASIONAL MAX VALUES ELEVATED TO 800 - 1100 OHMS WITH 3 MAX VALUES IN THE LAST 3 WEEKS OF THE RECORD ENDING (B) (6) 2010 RANGING FROM 2129 TO 7376 OHMS. THERE WERE NO PATIENT COMPLICATIONS REPORTED RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    PT REVISED FOR DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BIOPROSTHESIS W/ THERMAFIX REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-09K2438

    Patients

    Seq Age Sex Outcome Treatment
    1 Death