BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLEX ESOPHAGEAL STENT

    MDR report key: 880340 · Received September 12, 2006

    Report

    Report Number
    6000146-2006-00007
    Event Type
    Malfunction
    Date Received
    September 12, 2006
    Date of Event
    August 29, 2006
    Report Date
    August 29, 2006
    Manufacturer
    RUSCH GMBH GERMANY/TELEFLEX MEDICAL
    Product Code
    EJW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT BEEN RECEIVED BY THIS MFR. AN EVAL HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE IF THE DEVICE MET ITS SPECS. 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 FEMALE PT UNDERWENT A THERAPEUTIC PLACEMENT OF A STENT FOR TREATMENT OF A REFRACTORY STRICTURE IN HER DISTAL ESOPHAGUS. THE DEVICE WAS PLACED IN 2006 (UNK FACILITY/UNK CLINICIAN). SOME TIME AFTER THE INITIAL PLACEMENT, THE STENT WAS NOTED TO HAVE MIGRATED TO THE PT'S STOMACH. THE CLINICIAN ATTEMPTED TO RETRIEVE THE INITIAL STENT WITHOUT SUCCESS. THE CLINICIAN PLACED ANOTHER POLYFLEX STENT WHICH ALSO MIGRATED TO THE PT STOMACH (PLEASE NOTE ASSOCIATED MEDWATCH 6000146-2006-00008 ATTACHED). THE PT STRICTURE STATUS WAS UNCHANGED. THE CLINICIAN HAS INDICATED THAT THE DEVICES ARE NOT ABLE TO BE REMOVED ENDOSCOPICALLY. IT IS UNK IF THE PT HAS HAD SUBSEQUENT SURGICAL INTERVENTION TO REMOVE THE MIGRATED DEVICES. THERE IS NO FURTHER INFO AVAILABLE AT THIS TIME. REQUESTS FOR AN UPDATE TO THE PT STATUS HAVE NOT BEEN PROVIDED AT TIME OF THIS SUBMISSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR