MAUDE Adverse Event Report: INTERSECT ENT PROPEL MINI SINUS IMPLANT; DRUG ELUTING SINUS STENT

Model Number 60011

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

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 and route used: 370 ug; drug eluting implant placed during surgery; intra-sinal c5: 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 3008301917-2018-00002, 3008301917-2018-00003, 3008301917-2018-00004 for additional implants placed in the ethmoid and frontal sinuses.

Event Description

The physician reported a csf leak during the first follow-up visit approximately 1 week following a sinus surgery that included placement of four sinus implants bilaterally in the recess of the frontal and ethmoid sinuses.The surgery was a bilateral revision fess that included polypectomy and balloon sinuplasty.This patient had previously undergone multiple sinus surgeries for removal of mucosal polyps (dates unknown).During placement of the implants the physician observed that the amount of surrounding bone was minimal and the dura was still compromised from previous surgeries.The physician reported they were not overly aggressive with the microdebrider and had ballooned both frontal sinuses with a guided system.The leak was not observed immediately following surgery.During the first follow-up visit (1 week post-op), patient complained of headaches and clear fluid drainage.The leak was observed by endoscopic examination and reported to be coming from the left ethmoid cavity.The physician described the dura as wet but not torn; the physician maintained the patient on oral antibiotics and bedrest.The implant was visible and not disturbed.At a subsequent visit (b)(6) 2018 the csf leak had not resolved and the patient was referred to another physician for endoscopic closure of the csf leak.It was reported that the patient has recovered and has had no further issues.

• Brand Name: PROPEL MINI SINUS IMPLANT
• Type of Device: DRUG ELUTING SINUS STENT
• Manufacturer (Section D): INTERSECT ENT; 1555 adams dr; menlo park CA 94025
• Manufacturer (Section G): INTERSECT ENT; 1555 adams dr; menlo park CA 94025
• Manufacturer Contact: amy wolbeck ; 1555 adams dr; menlo park, CA 94025
• MDR Report Key: 7697125
• MDR Text Key: 114289062
• Report Number: 3008301917-2018-00001
• Device Sequence Number: 1
• Product Code: OWO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR