MAUDE Adverse Event Report: INTERSECT ENT; DRUG-ELUTING SINUS STENT

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

Patient Problem Cellulitis (1768)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

Although, the medical reviewer believed the event was not device-related, the event is being reported to be conservative.Intersect ent is reporting this event as an adverse event based on the information received and the remote possibility the complication was caused by use of the implant rather than merely correlated with its placement.Orbital cellulitis is an uncommon complication of sinusitis.Orbital complications from surgery typically occur intraoperatively or in the immediate postoperative period.The treating physician indicated that other than the radiographic appearance of the patient's sinuses, the patient's sinus exam did not seem to match the severity of her orbital symptoms.The instructions for use lists infection as a potential risk associated with use of the steroid-eluting sinus implant(s).The patient's weight is not known to the manufacturer.The physician could not recollect the model of the device used, was either propel (model 70011) or propel mini (model number 60011).Date of the implant was approximately 3 to 3 ½ weeks prior to the event.The following is being provided as this device is a combination product: name: propel or propel mini, dose, frequency & route used: (1) 370 ug implant, diagnosis for use: sinus surgery.Combination product -yes.Reference mfr report number 3008301917-2017-00009 for first implant in this bilateral case.

Event Description

Patient underwent bilateral total sphenoethmoidectomy, maxillary antrostomy as well as balloon sinuplasty of the frontal sinuses.Bilaterally steroid-eluting sinus implants were placed in the ethmoid cavities.Bioresorbable nasal packing product was placed within the implant on each side.No polyps or infection were encountered during surgery.Blood loss was minimal and the surgery was uneventful.Postoperatively, the patient was on 10 days of oral antibiotics and twice daily saline irrigations.Postoperative appointments were planned weekly.The first appointment reportedly went well.The patient missed her second appointment.Approximately 3 to 3 ½ weeks postoperatively the patient presented to the emergency room with right eye swelling, a ct was obtained and patient was diagnosed with a right preseptal orbital cellulitis.It was noted that the patient reported that her nose and sinuses felt very good.Endoscopy performed showed no clear evidence of mucopurulence or infection, there was no violation of the lamina, and the implants looked fine, with no evidence of adherent crusting.The patient improved rapidly on intravenous antibiotics and was eventually discharged to home without further medical or surgical intervention.

• 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 ; 6506412115
• MDR Report Key: 6659342
• MDR Text Key: 78128737
• Report Number: 3008301917-2017-00010
• 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: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 26 YR