BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 1691786 · Received May 18, 2010

    Report

    Report Number
    2015691-2010-13386
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    April 23, 2010
    Report Date
    April 23, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY REPORT WAS NOT POSSIBLE DUE TO NO LOT / SERIAL NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B) (4) = A BLOOD CLOT BROKE/DISLODGED OFF THE SEWING CLOTH. NO PRODUCT RETURN. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH VIA TELEPHONE CALL FROM HVT SALES REPRESENTATIVE. A DEVICE HISTORY RECORD REVIEW IS CURRENTLY IN PROCESS. REQUESTS WERE MADE VIA E-MAIL FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED, DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT C16000 ANALYZER GENERATED AN INITIAL CHLORIDE RESULT OF 90 MMOL/L. THE SAMPLE WAS REPEATED 2 TIMES WITH RESULTS OF 102 MMOL/L BOTH TIMES. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIED ONE DAY AFTER A 3300TFX OF UNKNOWN SIZE WAS IMPLANTED. A BLOOD CLOT BROKE/DISLODGED OFF THE SEWING CLOTH. NO ADDITIONAL INFORMATION WAS PROVIDED. ONLY THE MODEL NUMBER WAS PROVIDED; THEREFORE, THE SMALLEST DEVICE SIZE WAS USED IN ORDER TO ENTER THE PRODUCT ID. THIS INFORMATION WILL BE UPDATED AS SOON AS THE CORRECT SIZE IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R