RELIEVA STRATUS MICROFLOW SPACER

Description of Event or Problem

THIS EVENT OCCURRED IN ONE PT. ON (B)(6) 2009, THE PT HAD FUNCTIONAL ENDOSCOPIC SINUS SURGERY, IN WHICH BALLOON SINUSPLASTY DEVICES WERE USED TO DILATE BOTH FRONTAL SINUSES, ALONG WITH BILATERAL FRONTAL SINUS SPACER IMPLANTATION. ON (B)(6) 2009, 34 DAYS LATER, THE PHYSICIAN ATTEMPTED TO REMOVE THE FRONTAL SINUS SPACERS IN OFFICE, BUT WAS UNABLE TO VISUALIZE THEM. THE FRONTAL SPACER IFU IS ONLY APPROVED FOR 14 DAY IMPLANTATION. ON (B)(6) 2009, DAY 38, THE PT WAS TAKEN TO THE OPERATING ROOM TO REMOVE THE FRONTAL SPACERS UNDER FLUOROSCOPY. THE RIGHT FRONTAL SPACER WAS REMOVED WITHOUT ISSUE. THE LEFT WAS ALSO REMOVED, BUT WAS FOUND TO BE MISSING ONE OF THE RETENTION WINGS. 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. AFTER FURTHER EXPLORATION DURING THE SAME SURGICAL PROCEDURE, THE DETACHED RETENTION WING WAS RETRIEVED. ON (B)(6) 2009, THE PHYSICIAN REPORTED THAT THE PT WAS DOING WELL.

Additional Manufacturer Narrative

THE DEVICE WAS NOT AVAILABLE FOR RETURN. THE LOT NUMBER OF THE FRONTAL SPACER, (B)(4), WAS REVIEWED. 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.