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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device biliary stent system for benign strictures
Definition A benign stricture biliary stent system is a prescription device intended for treatment of benign biliary strictures. Stents are intended to be left indwelling for a limited amount of time and subsequently removed. The device consists of a metal stent and a delivery system intended to place the stent in the biliary ducts.
Product CodePNB
Regulation Number 876.5011
Device Class 2

MDR Year MDR Reports MDR Events
2019 46 46
2020 48 48
2021 29 29
2022 16 16
2023 27 27
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 64 64
Migration 41 41
Positioning Problem 32 32
Break 26 26
Material Deformation 25 25
Obstruction of Flow 21 21
Use of Device Problem 18 18
Positioning Failure 13 13
Detachment of Device or Device Component 11 11
Material Integrity Problem 10 10
Activation Failure 9 9
Device Markings/Labelling Problem 9 9
Difficult or Delayed Positioning 8 8
Device Stenosis 7 7
Human-Device Interface Problem 6 6
Premature Activation 6 6
Failure to Advance 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Difficult to Advance 3 3
Appropriate Term/Code Not Available 3 3
Defective Device 3 3
Activation, Positioning or Separation Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Output Problem 1 1
Wrong Label 1 1
Device-Device Incompatibility 1 1
Unraveled Material 1 1
Material Puncture/Hole 1 1
Entrapment of Device 1 1
Mechanical Problem 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 63 63
No Consequences Or Impact To Patient 60 60
No Code Available 28 28
Jaundice 9 9
Insufficient Information 7 7
Abdominal Pain 7 7
Fever 4 4
Injury 4 4
Depression 3 3
Inflammation 3 3
Liver Damage/Dysfunction 3 3
Pain 3 3
Hemorrhage/Bleeding 2 2
Fatigue 2 2
Death 2 2
Anxiety 2 2
Failure of Implant 2 2
No Known Impact Or Consequence To Patient 2 2
Thrombosis/Thrombus 1 1
Pancreatitis 1 1
Discomfort 1 1
Chills 1 1
Obstruction/Occlusion 1 1
Pseudoaneurysm 1 1
Weight Changes 1 1
Foreign Body In Patient 1 1
Dehydration 1 1
Emotional Changes 1 1
Chest Pain 1 1
Feeding Problem 1 1
Fistula 1 1
Hypoxia 1 1
Itching Sensation 1 1
Perforation 1 1
Pneumonia 1 1
Tissue Damage 1 1
Perforation of Vessels 1 1
Vomiting 1 1

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