BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS PERICARDIAL PATCH

    MDR report key: 1402345 · Received June 16, 2009

    Report

    Report Number
    2015691-2009-10837
    Event Type
    Death
    Date Received
    June 16, 2009
    Date of Event
    April 9, 2007
    Report Date
    May 26, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXZ
    PMA / PMN Number
    K833763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. A DEVICE HISTORY RECORD REVIEW IS IN PROCESS. TWO REQUESTS WERE MADE (VIA E-MAIL) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AND NO DEVICE WAS RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT. A NOTATION WAS MADE BY THE HOSPITAL OR STAFF ON THE DEVICE IMPLANT DATA CARD INDICATING THE PATIENT DIED IN THE OR. IT WAS ALSO INDICATED ON THE CARD THAT THERE WAS A PREVIOUS PROSTHESIS REMOVED (MECHANICAL VALVE - MANUFACTURER AND MODEL UNKNOWN) AND CONCOMITANT CORONARY ARTERY BYPASS WAS PERFORMED. THE PATIENT HAD BEEN ADMITTED IN 2007 AND OPERATED THE FOLLOWING MONTH. THERE IS NO INFORMATION PROVIDED AS TO THE USE OF THE REPORTED DEVICE AND THERE IS NO INFORMATION PROVIDED TO SUGGEST THAT THE CAUSE OF DEATH WAS DEVICE RELATED. AT 08/21/2009, THERE HAS BEEN NO RESPONSE FROM THE SURGEON RELATING TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER IMPLANT DURATION OF ZERO DAYS, 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 EDWARDS PERICARDIAL PATCH PERICARDIAL PATCH DXZ EDWARDS LIFESCIENCES 4700 R-07E1023

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death