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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)
2019 2020 2021 2022 2023 2024
8 3 1 3 0 0

MDR Year MDR Reports MDR Events
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 3 5
Improper or Incorrect Procedure or Method 1 1
Defective Device 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fungal Infection 1 3
Unspecified Infection 1 1
Purulent Discharge 1 1
Pain 1 3
Headache 1 1
Loss of consciousness 1 1
Necrosis 1 3
Blurred Vision 1 1
Syncope/Fainting 1 1
No Consequences Or Impact To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Burning Sensation 1 1
Implant Pain 1 1

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