RELIEVA STRATUS MICROFLOW SPACER

Additional Manufacturer Narrative

A REVIEW OF THE HISTORICAL DATA DEMONSTRATES AN OVERALL COMPLAINT RATE OF (B)(4) FOR COMPLAINTS RELATED TO FRONTAL SPACER WING DETACHMENT. THE LOT AVAILABLE TO THE FACILITY WAS NOTED TO BE LOT # 100127D. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED. THE PRODUCT MET SPECIFICATION. CAPA (B)(4) WAS OPENED TO INVESTIGATE THE FAILURE MODE OF "DETACHED RETENTION WING." IN ADDITION, AN UPDATED SPACER MPI FOR OPTIMIZED PROCESS BECAME ACTIVE ON (B)(4) 2009. THIS IS THE FIRST WING DETACHMENT TO OCCUR SINCE THE PROCESS IMPROVEMENTS HAVE BEEN PUT IN PLACE. (B)(4). NOTE, THE MICROFLOW SPACER (FRONTAL) IS INDICATED FOR USE AS A POSTOPERATIVE SPACER TO MAINTAIN AN OPENING TO THE FRONTAL SINUSES FOLLOWING SURGERY, AS STATED IN THE IFU. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADDITIONAL INFORMATION AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.

Description of Event or Problem

THIS EVENT OCCURRED IN ONE PATIENT. ON (B)(6) 2010, SEVENTY DAYS AFTER IMPLANTATION, A PATIENT WITH CYSTIC FIBROSIS AND CHRONIC SINUSITIS HAD TWO STRATUS FRONTAL SPACER IMPLANTS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTED BOTH TO OFFER RESISTANCE. NOTE, THE IFU RECOMMENDS SPACER IMPLANTATION UP TO 28 DAYS. OF THE TWO SPACERS REMOVED, ONE WAS NOTED TO BE MISSING A RETENTION WING. NOTE, THE RETENTION WING IS A SMALL COMPONENT OF THE SPACER MADE OF NITINOL AND IS L-SHAPED IN APPEARANCE. X-RAYS CONFIRMED THE DETACHED RETENTION WING WAS PRESENT IN THE PATIENT¿S FRONTAL SINUS. THE PHYSICIAN FELT THAT LEAVING THE NON-REACTIVE RETENTION WING COULD NOT POSE EXCESSIVE RISK TO THE PATIENT. THE PATIENT HAS SINCE BEEN SEEN BY THE PHYSICIAN AND HAS BEEN NOTED TO BE FREE OF ANY COMPLICATIONS RELATED TO THE SINUS TREATMENT.