BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS PERICARDIAL PATCH

    MDR report key: 1677665 · Received May 8, 2010

    Report

    Report Number
    2015691-2010-13308
    Event Type
    Death
    Date Received
    May 8, 2010
    Date of Event
    December 15, 2009
    Report Date
    April 7, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXZ
    PMA / PMN Number
    K833763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. PATIENT ALSO HAD TWO OTHER DEVICES IMPLANTED; (B) (6). THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER (VIA FAX), A COPY OF THE OPERATIVE REPORT FOR A PREVIOUS SURGERY AND A COPY OF THE EPIC CARE EXPIRATION SUMMARY WERE RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. AN UNKNOWN SIZE TAXUS EXPRESS2 DRUG ELUTING STENT WAS PLACED IN AN UNKNOWN VESSEL. THREE TO FOUR YEARS LATER, VERY LATE STENT THROMBOSIS OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.2 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF A OPERATIVE REPORT FOR THE PREVIOUS SURGERY AND A COPY OF THE EPIC CARE EXPIRATION SUMMARY WERE RECEIVED. PER THE OPERATIVE REPORT OF (B) (6) 2009, "THE PATIENT LEFT THE OPERATING ROOM IN CRITICAL CONDITION." PER THE EPIC CARE EXPIRATION SUMMARY, "ON (B) (6) 2009, DISCUSSION WAS MADE WITH THE FAMILY AND WIFE OF THE PATIENT AMONG IN ACCORDANCE WITH THE REST OF THE FAMILY REQUESTED STOPPING FURTHER THERAPY, SO THE COMFORT CARE MEASURES WERE IMPLEMENTED AND THE PATIENT EXPIRED ON (B) (6) 2009 IN THE AFTERNOON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS PERICARDIAL PATCH PERICARDIAL PATCH DXZ EDWARDS LIFESCIENCES 4700 R-09J2064

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death