BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLEX SINGLE-USE ESOPHAGEAL STENT SYSTEM

    MDR report key: 753741 · Received August 14, 2006

    Report

    Report Number
    6000146-2006-00006
    Event Type
    Injury
    Date Received
    August 14, 2006
    Date of Event
    August 14, 2006
    Report Date
    August 14, 2006
    Manufacturer
    RUSCH GMBH GERMANY/ TELEFLEX MEDICAL
    Product Code
    EJW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION SUPPLIED IN SECTION F WAS COMPLETED BY THE MANUFACTURER BASED ON INFORMATION 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. 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.

    Description of Event or Problem · 1

    THE COMPLAINANT HAS REPORTED THAT A PATIENT (AGE AND GENDER UNKNOWN) WITH ESOPHAGEAL MALIGNANCY/ESOPHAGEAL CARCINOMA UNDERWENT A THERAPEUTIC POLYFLEX SINGLE-USE ESOPHAGEAL STENT SYSTEM PLACEMENT. A SOFT GASTROSCOPE WAS REPORTED USED AND DURING THE PROCEDURE IT WAS NOTED THAT THE STENT PERFORATED THE DISTAL ESOPHAGUS. THE PROCEDURE WAS THEN SHORTED DUE TO THE EVENT, THE STENT WAS REMOVED AND THE PATIENT UDERWENT AN OPEN ESOPHAGEAL PERFORATION REPAIR, SANS TRACHEOSTOMY. THE PATIENT CONDITION IS REPORTED GOOD AND RECOVERING WELL, YET WITH A POOR PROGNOSIS DUE TO THE ESOPHAGEAL MALIGNANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLEX SINGLE-USE ESOPHAGEAL STENT SYSTEM ESOPHAGEAL STENT EJW RUSCH GMBH GERMANY/ TELEFLEX MEDICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention