BEUDAMED
    FDA Adverse Event Death Summary report: N

    POLYFLEX ESOPHAGEAL STENT

    MDR report key: 726906 · Received June 20, 2006

    Report

    Report Number
    6000146-2006-00003
    Event Type
    Death
    Date Received
    June 20, 2006
    Date of Event
    May 7, 2006
    Report Date
    May 31, 2006
    Manufacturer
    RUSCH GMBH GERMANY/TELEFLEX MEDICAL
    Product Code
    ESW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION SUPPLIED IN SECTION F WAS COMPLETED BY THE MANUFACTURER BASED ON INFO OBTAINED FROM THE USER FACILITY. ANY INFORMATION NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA. H4- USER FACILITY WAS UNABLE TO SUPPLY THE CORRECT LOT NUMBER OF THE DEVICE USED, CONSEQUENTLY, THE MANUFACTURE DATE OF THE DEVICE IS UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE IF THE DEVICE MET SPECIFICATION. SHOULD FURTHER RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED UNDER THE APPROPRIATE SEQUENCE NUMBER. WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT AT THIS TIME. OUR DIRECTIONS FOR USE OUTLINE APPROPRIATE PLACEMENT, ACCESS AND MAINTENANCE PROCEDURES. BSC REFERENCE # TW135912/A00025140. DATE FILED: 20 JUNE 2006

    Description of Event or Problem · 1

    THE COMPLAINANT HAS REPORTED THAT A CHILD SUSTAINED AN ESOPHAGEAL ALKALI BURN AS OF A RESULT OF ACCIDENTAL INGESTION OF A LYE SOLUTION. THE PT HAD A THERAPEUTIC PLACEMENT OF A POLYFLEX ESOPHAGEAL STENT IN 2005. THE EVENT INFORMATION STATES THAT THE STENT MIGRATED INTO THE STOMACH. FIVE MONTHS LATER, THE MIGRATED STENT WAS REMOVED WITHOUT ISSUE. PLEASE NOTE ASSOCIATED MEDWATCH REPORT 6000146-2006-00002. THE REPLACEMENT POLYFLEX STENT WAS PLACED SUCCESSFULLY WITHOUT ISSUE. THE PT WAS MONITORED FOR 2 DAYS POST STENT PLACEMENT. ON THE DAY OF DISCHARGE , THE PT HAD NO PROBLEMS EATING. THE CLINICIAN REPORTS THE PT EXPIRED THE FOLLOWING DAY. THE CAUSE OF DEATH WAS ATTRIBUTED TO BLOOD COAGULATION IN THE TRACHEA DUE TO HEMORRHAGE. THE HEMORRHAGE SITE WAS DUE TO A PERFORATION THAT WAS IDENTIFIED IN THE ESOPHAGUS AT AN AREA ABOVE THE LOCATION OF STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLEX ESOPHAGEAL STENT ESOPHAGEAL PROSTHESIS ESW RUSCH GMBH GERMANY/TELEFLEX MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Death