This patient had pre-existing history of a csf leak in the same location that had stopped spontaneously and that may have pre-disposed him for a csf leak.The treating physician does not believe the implants caused the csf leak.The cause of the csf leak is unknown.The relationship of the presence of the implants and reported event could not be confirmed.Intersect ent believes the event was not device-related.The event is being reported to be conservative.The sinus implant is intended for use in patients greater than or equal to 18 years of age following ethmoid or frontal sinus surgery to maintain patency of the ethmoid sinus or frontal sinus opening.The sinus implant separates and dilates surrounding mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces inflammation.The implant reduces the need for post-operative intervention such as surgical adhesion lysis and or use of oral steroids.Product instructions for use provide adequate directions.No issues were reported with the delivery system.The implant was deployed successfully.Risks associated with the use of this sinus implant are anticipated to be similar to those experienced by patients who undergo placement of other sinus implants or packing.Manifestation of a csf leak is a known potential surgical complication and may occur inadvertently due to the insertion of any surgical instrument.Patients weight, ethnicity and race are unknown.The following is being provided as this device is a combination product: name: propel mini.Dose, frequency & route used: 370 ug; drug eluting implant placed during surgery; intra-sinal.Diagnosis for use (indication): the sinus implant is intended for use in patients greater than or equal to 18 years of age following ethmoid or frontal sinus surgery to maintain patency of the ethmoid sinus or frontal sinus opening.Lot number is unknown; therefore, the expiration date and udi are unknown.Explant date: at the time of the event implants were in place; unknown if implant(s) were removed at a later date.Refer to mfr report numbers 3008301917-2018-00001, 3008301917-2018-00003, 3008301917-2018-00004 for additional implants placed in the ethmoid and frontal sinuses.
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