RELIEVA STRATUS MICROFLOW SPACER

Description of Event or Problem

THIS EVENT OCCURRED IN ONE PT. THE PT HAD ENDOSCOPIC SINUS SURGERY INCLUDING BALLOON DILATION OF BILATERAL FRONTAL SINUSES AND PLACEMENT OF BILATERAL FRONTAL STRATUS DEVICES ON (B)(6) 2009. IN THE COURSE OF THE ENDOSCOPIC SINUS SURGERY, THE PHYSICIAN USED A SHAVER TO PERFORM TURBINATE REDUCTIONS AND REMOVE POLYPS AND OTHER TISSUE. THE PT RETURNED TO CLINIC TWO WEEKS POST-OPERATIVELY ON (B)(6) 2009, AT WHICH TIME THE RIGHT FRONTAL STRATUS DEVICE WAS REMOVED EASILY BUT THE LEFT FRONTAL STRATUS DEVICE WAS DIFFICULT TO VISUALIZE. ACCORDING TO THE PHYSICIAN, THERE WAS AN EXCESSIVE AMOUNT OF POST-OPERATIVE SWELLING IN THE LEFT FRONTAL RECESS, WHICH HE ATTRIBUTED TO THE USE OF THE SHAVER IN REMOVING TISSUE IN THAT REGION. BECAUSE, THE PT EXPERIENCED DISCOMFORT WHILE THE PHYSICIAN ATTEMPTED TO LOCATE AND REMOVE THE LEFT FRONTAL STRATUS DEVICE IN THE OFFICE, THE PHYSICIAN DECIDED TO REMOVE THE DEVICE IN THE OPERATING ROOM ON (B)(6) 2009. (B)(6) CONFIRMED THAT THE LEFT FRONTAL STRATUS DEVICE HAD NOT MIGRATED FROM ITS INITIAL POSITION. THE REMOVAL OF THE DEVICE IN THE OPERATING ROOM WAS NOTED TO BE EASY WITHOUT INCIDENT OR COMPLICATIONS. AS OF (B)(6) 2009, THE PT CONTINUES TO DO WELL WITH NO COMPLICATIONS OR ISSUES.

Additional Manufacturer Narrative

THE DEVICE WAS NOT AVAILABLE FOR RETURN. THE LOT NUMBER OF THE FRONTAL SPACERS, (B)(4), WAS REVIEWED. A REVIEW OF THE DEVICE HISTORY RECORD AND HISTORICAL TRENDING WAS PERFORMED. THE PRODUCT MET SPECIFICATION.