BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERYX PROCEDURE KIT

    MDR report key: 1324145 · Received February 25, 2009

    Report

    Report Number
    3005099803-2008-01386
    Event Type
    Death
    Date Received
    February 25, 2009
    Date of Event
    July 17, 2005
    Report Date
    August 3, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH
    Product Code
    LMN
    PMA / PMN Number
    P020006
    Removal / Correction Number
    Z-0040-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. NOTE: THIS PRODUCT WAS REMOVED FROM THE GLOBAL MARKET IN SEPTEMBER 2005. BOSTON SCIENTIFIC CORPORATION NO LONGER PRODUCES THE REPORTED PRODUCT. PRODUCT UNAVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2005 THAT AN ENTERYX PROCEDURE, KIT WAS IMPLANTED (PATIENT AGE, GENDER AND WEIGHT UNKNOWN) THE PREVIOUS MONTH. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD AN AORTIC RUPTURE WHILE TAKING A SHOWER AT HOME AND DIED INSTANTLY. THE CAUSE OF DEATH ON THE DEATH CERTIFICATE WAS CITED AS CARDIAC TAMPONADE RELATED TO RUPTURE ANEURYSM OR AORTIC ARCH. OTHER RELATED FACTORS LISTED ON THE DEATH CERTIFICATE INCLUDED HYPERTENSION AND ATHEROSCLEROSIS. BASED ON THE INFORMATION PROVIDED ABOVE, THERE IS NO INDICATION THAT THE PATIENT'S EXPIRING WAS RELATED TO A BOSTON SCIENTIFIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERYX PROCEDURE KIT CERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES LMN BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH M00572600 40315

    Patients

    Seq Age Sex Outcome Treatment
    1 Death