BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS W/ THERMAFIX

    MDR report key: 1659196 · Received April 14, 2010

    Report

    Report Number
    2015691-2010-13124
    Event Type
    Malfunction
    Date Received
    April 14, 2010
    Date of Event
    March 15, 2010
    Report Date
    March 15, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FLAILED LEAFLET. EVALUATION SUMMARY: AS RECEIVED, THE VALVE IS ATTACHED TO THE HOLDER. NO INCONSISTENCIES DETECTED IN THE VALVE OR LEAFLETS. THE TAG WAS RETURNED, YET DETACHED FROM THE VALVE. (MODEL# 3000). X-RAY. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH VIA TELEPHONE CALL FROM (B) (4) SALES REPRESENTATIVE. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. DEVICE WAS RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: (B)(4) 2010 RESEARCH AND DEVELOPMENT CONCLUDED WITH THE FOLLOWING: THIS VALVE WAS NOT IMPLANTED DUE TO A "FLAILING LEAFLET DURING THE RINSING OF THE VALVE". THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. EDWARDS STANDARDIZED IN VITRO TESTING DEMONSTRATES THE VALVE IS FUNCTIONING PROPERLY AND MEETS THE FUNCTIONAL REQUIREMENTS PER ISO5840:2005. IT APPEARS THAT THE FLAILING LEAFLET OBSERVED BY THE CUSTOMER DURING THE RINSING PROCEDURE HAS NO MEASURABLE IMPACT ON THE FUNCTIONALITY OF THE VALVE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER.

    Description of Event or Problem · 1

    REPORTEDLY A 3000TFX, 25MM WAS DISCOVERED TO HAVE A FLAILING LEAFLET DURING THE RINSING OF THE VALVE, THEREFORE IT WAS NOT IMPLANTED. THE DEVICE IS AVAILABLE FOR RETURN AND WILL BE RETURNED BY SALES REPRESENTATIVE.

    Description of Event or Problem · 1

    A UNITED STATES CUSTOMER CONTACTED BIOMERIEUX, INC. ON 04/14/2010, INDICATING THAT IN (B)(6) 2010 A PATIENT HAD SEVERAL POSITIVE BLOOD CULTURE ISOLATES AFTER 3-5 DAYS. WHILE PREPARING THE ISOLATE FOR VITEK 2 GP CARD TESTING (ON THE VITEK 2 INSTRUMENT) IT WAS NOTED THAT THIS ISOLATE WAS SLOW GROWING. ON THE VITEK 2 THE ISOLATE ID'D AS (B)(6). THE TREATING PHYSICIAN QUESTIONED THE (B)(6) ID. IN (B)(6) 2009, THE SAME PATIENT WAS ADMITTED TO HOSPITAL AND A (B)(6) INFECTION WAS ID'D. (B)(6) WAS MANUALLY KEYED INTO A VITEK 2 SUSCEPTIBILITY (SUSC.) CARD AND THE ISOLATE WAS RESISTANT TO LEVOFLOXACIN. THE FEB. 2010 ISOLATE SHOWED SAME SUSC PATTERN AS THE ISOLATE FROM 2009. AS K. VARIANS IS NOT CLAIMED ON THE VITEK 2 SUSC. CARDS THE CUSTOMER TURNED TO LITERATURE AND EMPIRICALLY TREATED THE PATIENT WITH LEVOFLOXACIN AND METRONIDAZOLE DURING CONTINUED TESTING. THE LEVOFLOXACIN AND METRONIDAZOLE TREATMENT APPEARS SHORT BASED ON LAB REPORTS (THE ID AND MANUALLY KEYED SUSC TESTS WERE RUN WITHIN 2 DAYS OF EACH OTHER). THE PATIENT LATER EXPERIENCED HEART VALVE DAMAGE REQUIRING REPLACEMENT, WHICH MAY HAVE BEEN THE RESULT OF INAPPROPRIATE ANTIMICROBIAL TREATMENT WITH LEVOFLOXACIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS W/ THERMAFIX REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-09M2909

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention