RELIEVA STRATUS MICROFLOW SPACER

Description of Event or Problem

THE SURGEON REPORTED THAT IN REVIEWING THE CT SCAN OF THE PATIENT, SHE FOUND THE PATIENT HAD ACCLARENT STRATUS SPACER IMPLANTED IN THE FRONTAL RECESS FOR AN UNKNOWN DURATION. THE SURGEON DECIDED TO DISSECT AND REMOVE THE STRATUS. ACCLARENT WAS INFORMED THAT THE PATIENT IS DOING WELL REPORTED DID WELL AND NO ADDITIONAL CARE WAS REQUIRED.

Additional Manufacturer Narrative

ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADDITIONAL INFORMATION. THE REFERRING PHYSICIAN DID NOT RECALL PLACING THE STRATUS AND THE PATIENT AND HIS FAMILY WERE NOT TOLD THE STRATUS IMPLANT WAS USED. THE IMPLANTED STRATUS SPACER WAS REMOVED SUCCESSFULLY AND THE DEVICE WAS INTACT. THE ACCLARENT STRATUS DEVICES ARE APPROVED FOR IMPLANTATION FOR A 14 DAYS PERIOD. WHILE THE ACCLARENT STRATUS DEVICE WAS LEFT IN PLACE FAR BEYOND THE 14 DAYS INDICATION, THERE WAS NO INJURY TO THE PATIENT AND NO ADDITIONAL CARE BECAUSE OF RETAINED STRATUS DEVICE. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVALUATION, AND ITS WHEREABOUTS ARE UNKNOWN. NO OTHER DEVICES WERE RETURNED FOR EVALUATION FROM THE USER FACILITY. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.