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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


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC
  GRANTED 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 22 22
2018 48 48
2019 46 46
2020 48 48
2021 29 29
2022 16 16
2023 27 27
2024 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 85 85
Break 65 65
Migration 52 52
Positioning Problem 44 44
Material Deformation 35 35
Use of Device Problem 23 23
Positioning Failure 22 22
Obstruction of Flow 22 22
Detachment of Device or Device Component 19 19
Device Stenosis 15 15
Material Integrity Problem 13 13
Difficult or Delayed Positioning 11 11
Activation Failure 11 11
Device Markings/Labelling Problem 10 10
Premature Activation 10 10
Adverse Event Without Identified Device or Use Problem 7 7
Failure to Advance 6 6
Human-Device Interface Problem 6 6
Difficult to Advance 5 5
Appropriate Term/Code Not Available 5 5
Activation, Positioning or Separation Problem 5 5
Migration or Expulsion of Device 4 4
Defective Device 4 4
Device Contamination with Chemical or Other Material 2 2
Output Problem 1 1
Entrapment of Device 1 1
Mechanical Problem 1 1
Unraveled Material 1 1
Partial Blockage 1 1
Wrong Label 1 1
Material Puncture/Hole 1 1
Unsealed Device Packaging 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 122 122
No Clinical Signs, Symptoms or Conditions 81 81
No Code Available 31 31
Jaundice 12 12
Abdominal Pain 8 8
Insufficient Information 7 7
Inflammation 4 4
No Known Impact Or Consequence To Patient 4 4
Fever 4 4
Injury 4 4
Hemorrhage/Bleeding 4 4
Liver Damage/Dysfunction 3 3
Depression 3 3
Pain 3 3
Death 2 2
Fatigue 2 2
Failure of Implant 2 2
Vomiting 2 2
Anxiety 2 2
Unspecified Infection 1 1
Weight Changes 1 1
Pancreatitis 1 1
Emotional Changes 1 1
Perforation 1 1
Itching Sensation 1 1
Obstruction/Occlusion 1 1
Peritonitis 1 1
Chills 1 1
Foreign Body In Patient 1 1
Thrombosis/Thrombus 1 1
Chest Pain 1 1
Discomfort 1 1
Dehydration 1 1
Pneumonia 1 1
Perforation of Vessels 1 1
Feeding Problem 1 1
Hypoxia 1 1
Tissue Damage 1 1
Pseudoaneurysm 1 1
Fistula 1 1

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