POLYFLEX SINGLE-USE ESOPHAGEAL STENT SYSTEM

Description of Event or Problem

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.

Additional Manufacturer Narrative

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.