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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drug-eluting sinus stent
Definition Mechanically maintain patency following ethmoid sinus surgery. By also eluting drugs, reduce the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.
Product CodeOWO
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 1 3 8 4 2 5 8 4 8 3 1 3 0 0

MDR Year MDR Reports MDR Events
2014 6 6
2015 6 6
2016 6 6
2017 10 10
2018 4 4
2019 1 1
2020 3 5
2021 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25 27
Migration or Expulsion of Device 5 5
Appropriate Term/Code Not Available 2 2
Positioning Problem 1 1
Insufficient Information 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Device 1 1
Activation, Positioning or Separation Problem 1 1
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6 8
Cerebrospinal Fluid Leakage 5 5
Foreign Body Reaction 4 4
Headache 3 3
Blurred Vision 3 3
Fungal Infection 3 5
Choking 3 3
Inflammation 3 3
Intraocular Pressure Increased 2 2
Perforation 2 2
Scarring 2 2
Swelling 2 2
Hypersensitivity/Allergic reaction 2 2
Bacterial Infection 2 2
Cellulitis 2 2
Purulent Discharge 1 1
Edema 1 1
Unspecified Infection 1 1
Herpes 1 1
Burning Sensation 1 1
No Consequences Or Impact To Patient 1 1
Discomfort 1 1
Loss of consciousness 1 1
Necrosis 1 3
Sleep Dysfunction 1 1
Surgical procedure, additional 1 1
No Code Available 1 1
Syncope/Fainting 1 1
Implant Pain 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Intersect ENT, Inc. II Dec-08-2022
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