RELIEVA STRATUS MIRCOFLOW SPACER
Received Jul 2, 2012 · Event occurred Feb 5, 2011
Report 3005172759-2012-00024 · MDR key 2652462
Device
Generic name
Stratus Ethmoid Spacer
Manufacturer
Acclarent, Inc.Model number
BC1417RSCatalog number
BC1417RS
Lot number
100426C/101013A
Product problems
- Detachment Of Device Component
- Migration or Expulsion of Device
Patient
UNK
- Foreign Body In Patient
Narrative
Description of Event or Problem
THE PHYSICIAN REPORTED THAT THE PT FELT THAT SHE SWALLOWED ONE OF THE STRATUS DEVICES THAT DISLODGED DUE TO SNEEZING. THE PHYSICIAN CONFIRMED THAT THE ETHMOID SPACER WAS DISLODGED SINCE HE COULD ONLY SEE ONE DEVICE. THE PHYSICIAN ALSO CONFIRMED THAT THERE WAS NO AIRWAY ISSUE OTHER THAN PT'S USUAL ASTHMA. ON (B)(6) 2011, THE OTHER SPACER HAD BEEN REMOVED. THE PT CONTINUES TO HAVE NO EFFECT FROM THE POTENTIAL SWALLOWED STRATUS SPACER 16 DAYS AFTER THE EVENT.
Additional Manufacturer Narrative
THE SURGEON STATED ALL ACCLARENT DEVICES FUNCTIONED AS INTENDED. THE SURGEON SUGGESTED THAT AS THE STEROIDS WITHIN THE STRATUS ELUTED, THE POLYPS RESOLVED AND THE SPACER CAME LOOSE. THE PHYSICIAN DID NOT FEEL THAT THE ASTHMA IS IN ANYWAY RELATED TO THE PROCEDURE OR SWALLOWED STRATUS. THE VP OF MEDICAL AFFAIRS STATED THAT THERE WASN'T ANY ADVERSE EVENT FROM THE SWALLOWED IMPLANT. THE DEVICE IN THE REPORTED EVENT WAS NOT RETURNED FOR EVAL AND ITS WHEREABOUTS IS UNK. PRODUCTION RECORDS WERE REVIEWED AND NO DEVIATIONS WERE NOTED THAT WOULD LIKELY CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.
Remedial action
- Other