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

Patient Problems Purulent Discharge (1812); Headache (1880); Blurred Vision (2137); Burning Sensation (2146); Implant Pain (4561)

Event Date 11/08/2023

Event Type  Injury  

Event Description

I had a balloon dilation of my eustachian tubes and sinuses (b)(6) 2023 by dr.(b)(6) of (b)(6) in (b)(6).I was due for a post op two weeks later, but went in 2 days early (on a monday) due to pain, headaches and blurry vision.Apparently, i had a propel stent inserted on my surgery (b)(6).It was supposed to break down and dissolve.That sunday night ((b)(6)) i had pulled out a small piece of hard plastic from my right nostril.That, along with the pain, is what lead me to go neck to my ent on monday the (b)(6).I had several pieces of the stent painfully removed from both of my nostrils.They could be compared to the pieces of plastic that hold clothes tags onto clothes.They were hard and pokey, almost like having a bunch of little "fish bones" (as the assistant (b)(6) put it), in my sinuses.I took pictures of the bloody, mucus and stabbed covered plastic pieces that were removed.I'm due for another check up in a month with the surgeon that used the propel device.I was made aware yesterday ((b)(6)) that my appointment originally made with (b)(6) had to be rescheduled because he left the practice.I still have a burning pain in my both nostrils along with large, crusty, yellow, bloody secretions.

• Brand Name: PROPEL
• Type of Device: DRUG-ELUTING SINUS STENT
• Manufacturer (Section D): INTERSECT ENT
• MDR Report Key: 18326380
• MDR Text Key: 330598366
• Report Number: MW5149245
• Device Sequence Number: 1
• Product Code: OWO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/09/2023

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2023
• Patient Sequence Number: 1
• Treatment: 10MG AMBIEN. ; 200MG IBUPROFEN.; 60MG FLUOXETINE.; VIENVA DAILY BIRTH CONTROL PILL.
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic