RELIEVA STRATUS MICROFLOW SPACER

Description of Event or Problem

THIS EVENT OCCURRED IN ONE PT. ON (B)(6) 2009, THE PT UNDERWENT TREATMENT OF THE LEFT AND RIGHT FRONTAL SINUSES. TWO RELIEVA STRATUS SPACERS WERE IMPLANTED BILATERALLY. AFTER 16 DAYS OF IMPLANTATION, THE RIGHT SPACER WAS REMOVED WITHOUT COMPLICATION. THE LEFT WAS ALSO REMOVED, AND UPON OBSERVATION, THE SPACER WAS NOTED TO BE MISSING A RETENTION WING. THE RETENTION WING IS A SMALL COMPONENT OF THE SPACER MADE OF NITINOL. THIS COMPONENT IS L-SHAPED IN APPEARANCE, MADE FROM WIRE MEASURING 2 MM IN DIAMETER. THE PHYSICIAN STATED THAT THERE WAS NO EXCESSIVE FORCE UPON REMOVAL, AND NO PAIN OR DISCOMFORT WAS EXPERIENCED BY THE PT. X-RAYS SHOWED THE DETACHED RETENTION WING WAS PRESENT IN THE LEFT FRONTAL SINUS. WHILE THE PHYSICIAN FELT THAT LEAVING THE NON-REACTIVE RETENTION WING WOULD NOT POSE EXCESSIVE RISK TO THE PT, UPON CONSULTATION WITH THE PT, THE PHYSICIAN OPTED TO REMOVE THE RETENTION WING. ON THAT SAME DATE, IT WAS SUCCESSFULLY REMOVED IN THE OPERATING ROOM UNDER FLUOROSCOPY WITHOUT INCIDENT. THE PT REMAINED ASYMPTOMATIC. PT FOLLOW-UP WAS PERFORMED ON (B)(6) 2009. AT THAT TIME, THE PHYSICIAN CONFIRMED THE PT HAD NO SYMPTOMS OR ISSUES.

Additional Manufacturer Narrative

ADD'L MANUFACTURE DATE: 08/2009. BOTH THE SPACER AND THE DETACHED WING WERE SHIPPED TO ACCCLARENT FOR EXAMINATION AND TESTING. THE DEVICE WAS RETURNED ON (B)(6) 2009. THE FRONTAL SPACER WAS CONFIRMED TO HAVE A WING DETACHMENT. THE IMPLANTED SPACER'S LOT INFO WAS NOT AVAILABLE, HOWEVER TWO LOTS, 090710B AND 090812B, WERE AVAILABLE TO THE FACILITY. THE EXPIRATION DATES OF THOSE TWO LOTS ARE 07/2011 AND 8/2011. A REVIEW OF THE DEVICE HISTORY RECORD AND HISTORICAL TRENDING WAS PERFORMED. THE PRODUCT MET SPEC. WE WILL CONTINUE TO INVESTIGATE THIS COMPLAINT, IF THERE IS ANY RELEVANT INFO FOUND, A SUPPLEMENTAL MEDWATCH FORM WILL BE FILED.