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

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

Patient Problem Unspecified Infection (1930)

Event Date 11/23/2018

Event Type  Injury  

Event Description

Had sinus surgery on (b)(6) 2015 and propel sinus implants were used without my knowledge.Surgeon stated 4 large implants were used 2 in each sinus.On (b)(6) 2018 the implants began to release 30 to 45 days after surgery as they were supposed to per surgeon.Implants have caused chronic sinus infects since surgery.Intersect ent was supposed to have tested sample of the product that released on (b)(6) 2018 in (b)(6).Was advised testing was not completed and sample was discarded.I have photos of sample prior to release over to intersect ent.Do you have a picture of the product?: yes.Fda safety report id # (b)(4).

• Brand Name: PROPEL SINUS IMPLANT
• Type of Device: DRUG-ELUTING SINUS STENT
• Manufacturer (Section D): INTERSECT ENT
• MDR Report Key: 9417549
• MDR Text Key: 169803170
• Report Number: MW5091451
• Device Sequence Number: 2
• 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: 12/02/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 54 YR
• Patient Weight: 127