BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1737462 · Received June 25, 2010

    Report

    Report Number
    2015691-2010-13629
    Event Type
    Death
    Date Received
    June 25, 2010
    Date of Event
    April 29, 2010
    Report Date
    June 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION (ON 06/07/2010 AND 06/11/2010); HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AND NO DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF AN INFUSOR SV2 RUPTURED DURING PATIENT USE. THE DEVICE WAS INFUSING AN UNKNOWN PATIENT WITH A SOLUTION OF 48 MILLILITERS 5-FLUOROURACIL AND 35 MILLILITERS SALINE WHEN THE RESERVOIR RUPTURED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.07 MONTHS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000 R-09J2071

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death