RELIEVA STRATUS MICROFLOW SPACER

Description of Event or Problem

THIS EVENT OCCURRED IN ONE PATIENT ON (B)(6) 2010. ACCLARENT'S AWARENESS OF THIS EVENT WAS ALSO (B)(4) 2010. A FRONTAL STRATUS MICROSPACER WAS IMPLANTED ON (B)(6) 2010 AS PART OF A REPEAT SURGERY TO TREAT A PATIENT WITH REOCCURRING RESTENOSIS. AFTER 57 DAYS OF PLANNED TIME FOR IMPLANTATION, THE SPACER WAS REMOVED. UPON OBSERVATION, THE SPACER WAS NOTED TO BE MISSING A RETENTION WING. THE RETENTION WING IS A SMALL NON-INFLAMMATORY COMPONENT OF THE SPACER MADE OF NITINOL. THIS COMPONENT IS L-SHAPED IN APPEARANCE, MADE FROM WIRE MEASURING APPROXIMATELY 0.2 MM IN DIAMETER. THE PHYSICIAN NOTED THAT GRANULATION TISSUE WAS PRESENT, WHICH IS SUSPECTED TO HAVE CONTRIBUTED TO GREATER REMOVAL FORCE. THE PHYSICIAN ALSO NOTED THAT THE DETACHED WING WAS EMBEDDED IN MUCOSA. ACCLARENT'S (B)(4) WAS NOTIFIED OF THE EVENT, AND HAS BEEN IN CONTACT WITH THE APPLICABLE ENT CONSULTANT. AS OF (B)(6) 2010, THE PATIENT WAS NOTED TO BE FREE OF ANY COMPLICATIONS OR ISSUES.

Additional Manufacturer Narrative

A REVIEW OF THE HISTORICAL DATA DEMONSTRATES AN OVERALL COMPLAINT RATE OF 0.016% FOR COMPLAINTS RELATED TO FRONTAL SPACER WING DETACHMENT. NO DEVICE(S) WERE AVAILABLE FOR RETURN. THE SPECIFIC LOT WAS NOT AVAILABLE; HOWEVER, A RANGE OF LOTS AVAILABLE TO THE FACILITY WAS DETERMINED. LOT HISTORY RECORD REVIEW WAS PERFORMED ON LOTS 090223A, 090311A, AND 090402A. ALL THREE POSSIBLE LOTS MET SPECIFICATION AND WERE NOTED TO BE MANUFACTURED PRIOR TO PROCESS IMPROVEMENTS PUT IN PLACE TO REDUCE WING DETACHMENT. 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. TO DATE, NO WING DETACHMENTS HAVE OCCURRED IN LOTS MANUFACTURED BEYOND THE PROCESS IMPROVEMENTS. NOTE, THE MICROFLOW SPACER (FRONTAL) IS INDICATED FOR USE AS A POSTOPERATIVE SPACER TO MAINTAIN AN OPENING TO THE FRONTAL SINUSES WITHIN THE FIRST 14 DAYS FOLLOWING SURGERY, AS STATED IN THE IFU. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADDITIONAL INFORMATION AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.