POLYFLEX ESOPHAGEAL STENT

Description of Event or Problem

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 INITIAL 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 (PLEASE NOTE ASSOCIATED MEDWATCH 6000146-2006-00007 ATTACHED). THE CLINICIAN THEN PLACED THIS POLYFLEX STENT WHICH ALSO MIGRATED TO THE PT STOMACH. 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.

Additional Manufacturer Narrative

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.