RELIEVA STRATUS MICROFLOW SPACER

Description of Event or Problem

PT, WHO WAS ON ANTICOAGULANTS AND ASPIRIN THERAPY, UNDERWENT A HYBRID SURGICAL PROCEDURE, UTILIZING BOTH ACCLARENT BALLOON SINUS DILATION TECHNOLOGY AND TRADITIONAL FESS INSTRUMENTS. THE PHYSICIAN IMPLANTED AN ACCLARENT FRONTAL STRATUS IN THE SPHENOID SINUS, WITH OFF LABEL TRIAMCINOLONE, WITHOUT INCIDENT. FOUR WEEKS LATER, THE NORMALLY SCHEDULED STRATUS EXPLANT OCCURRED. DURING SUBSEQUENT OBSERVATION, THE PT BEGAN TO BLEED FROM THE NASAL SIDE WHERE THE STRATUS WAS REMOVED. THE PT'S NOSE WAS PACKED AND THE PT ADMITTED TO THE HOSP. THE PT WAS ADMINISTERED PLATELETS AND FRESH FROZEN PLASMA TO COUNTER THE BLEEDING. THREE DAYS LATER ,THE PT WAS RELEASED. ONE WEEK LATER, THE PT WAS SEEN BY THE PHYSICIAN AND WAS REPORTED TO BE DOING WELL. AN ADD'L WEEK LATER, THE PT BEGAN TO BLEED AGAIN FROM THE NOSE AND WAS TREATED IN THE ER; THEN READMITTED TO THE HOSP FOR OBSERVATION. NO OTHER INTERVENTION WAS REQUIRED. THE DEVICE WAS NOT RETURNED FOR EVAL.

Additional Manufacturer Narrative

DURING THE PT'S INITIAL HOSP ADMISSION FOR BLEEDING, IT WAS LEARNED THAT THE PT HAD RESUMED HIS ANTICOAGULANT TREATMENT (PLAVIX) AS INSTRUCTED BY HIS PRIMARY CARE PHYSICIAN. HOWEVER, THE PT CHOOSE TO BEGIN TAKING TWO DAILY ADULT ASPIRINS INSTEAD OF ONE BABY ASPIRIN. DURING THE PT'S SECOND HOSP ADMISSION, THE TREATING PHYSICIAN NOTED AN ESCHAR ALONG THE PT'S MIDDLE TURBINATE. THE PHYSICIAN KNEW AND STATED THAT THE USE OF THE STRATUS IN THE SPHENOID SINUS AND USE OF THE TRIAMCINOLONE WAS OFF LABEL. IT IS SPECULATED THIS MAY BE THE RESULT OF THE STRATUS DEVICE LACERATING THE MUCOSA AS IT WAS BEING REMOVED FROM THE PT. NO PRODUCT MALFUNCTION WAS REPORTED AND OUTCOME OF THE PROCEDURE WAS VERY GOOD. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.