BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS

    MDR report key: 1718268 · Received June 10, 2010

    Report

    Report Number
    2015691-2010-13545
    Event Type
    Death
    Date Received
    June 10, 2010
    Date of Event
    March 24, 2010
    Report Date
    May 11, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION WAS RECEIVED. THE OPERATIVE REPORT AND AUTOPSY REPORT WAS ALSO PROVIDED, HOWEVER, THEY ARE NOT DICTATED IN ENGLISH. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE VALVE AS RETURNED IS SEWN IN A SECTION OF HOST ANATOMY. UNKNOWN MATERIAL IS DETECTED AT THE INFLOW AND THE OUTFLOW ASPECT. NO OTHER INCONSISTENCIES DETECTED OR IN THE X-RAY. LEAFLET DISRUPTION - INDETERMINABLE.ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE EVALUATION WAS COMPLETED ON 06/21/2010.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 79 MG/DL AND 300 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. ON 05/20/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), IT WAS LEARNED THAT THE CAUSE OF DEATH WAS PROSTHESIS THROMBOSIS.

    Description of Event or Problem · 1

    TECHNICIAN ALLEGED THAT THE RIGHT INTERMEDIATE SIDERAIL WAS NOT LATCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 09L316

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death