RELIEVA STRATUS MICROFLOW SPACER

Description of Event or Problem

ACCLARENT WAS NOTIFIED ON (B)(6) 2013 OF AN EVENT THAT OCCURRED ON (B)(6) 2013, DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WAS USED. THE SURGEON PERFORMED A FRONTAL SINUS BALLOON SINUPLASTY WITH NO DIFFICULTY. AFTER THAT, HE ELECTED TO INSERT AN ACCLARENT FRONTAL SINUS SPACER BILATERALLY. HE FILLED THE SPACER WITH TRIAMINCINALONE WHICH HE KNEW WAS OFF-LABEL USE. SEVERAL DAYS LATER, THE PT SNORTED BACKWARDS AND FELT PAIN IN THE NOSE. SHE WAS CERTAIN SHE SWALLOWED THE SPACER. THE SURGEON PERFORMED AN OFFICE NASAL ENDOSCOPIC EXAM AND COULD NOT SEE THE SPACER. THE CHEST AND ABDOMINAL X-RAYS WERE OBTAINED AND THE SURGEON DISCUSSED THE EVENT WITH A GASTROENTEROLOGIST AND BOTH AGREED THAT SINCE THERE WERE NO SYMPTOMS, NOTHING MORE WOULD BE DONE. NO FURTHER REPORTED SEQUELAE.

Additional Manufacturer Narrative

ACCLARENT FOLLOWED-UP ON THIS REPORT TO GATHER ADDITIONAL INFORMATION. VP OF MEDICAL AFFAIRS CONCLUDED THAT THE FRONTAL SINUS SPACER MOST LIKELY DISLODGED BOTH FROM THE FORCE OF THE SNORTING AND THE WIDE FRONTAL RECESS FROM THE PREVIOUS SURGERY. THERE WAS NO ADVERSE EVENT EXPERIENCED BY THE PT OTHER THAN THE NEED FOR X-RAYS. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVAL AND ITS WHEREABOUTS ARE UNK. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.