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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 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 79 79
Break 60 60
Migration 48 48
Positioning Problem 41 41
Material Deformation 32 32
Positioning Failure 22 22
Obstruction of Flow 22 22
Use of Device Problem 21 21
Detachment of Device or Device Component 17 17
Material Integrity Problem 12 12
Activation Failure 11 11
Difficult or Delayed Positioning 11 11
Premature Activation 10 10
Device Stenosis 10 10
Device Markings/Labelling Problem 9 9
Adverse Event Without Identified Device or Use Problem 6 6
Human-Device Interface Problem 6 6
Failure to Advance 6 6
Appropriate Term/Code Not Available 5 5
Difficult to Advance 4 4
Defective Device 4 4
Activation, Positioning or Separation Problem 4 4
Migration or Expulsion of Device 4 4
Device Contamination with Chemical or Other Material 2 2
Device-Device Incompatibility 1 1
Output Problem 1 1
Wrong Label 1 1
Unsealed Device Packaging 1 1
Material Puncture/Hole 1 1
Entrapment of Device 1 1
Mechanical Problem 1 1
Partial Blockage 1 1
Unraveled Material 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 66 66
No Code Available 31 31
Jaundice 12 12
Abdominal Pain 8 8
Insufficient Information 7 7
Fever 4 4
Injury 4 4
Inflammation 4 4
No Known Impact Or Consequence To Patient 4 4
Pain 3 3
Depression 3 3
Hemorrhage/Bleeding 3 3
Liver Damage/Dysfunction 3 3
Vomiting 2 2
Failure of Implant 2 2
Fatigue 2 2
Anxiety 2 2
Death 2 2
Foreign Body In Patient 1 1
Tissue Damage 1 1
Thrombosis/Thrombus 1 1
Chills 1 1
Perforation of Vessels 1 1
Emotional Changes 1 1
Unspecified Infection 1 1
Fistula 1 1
Chest Pain 1 1
Itching Sensation 1 1
Pneumonia 1 1
Discomfort 1 1
Perforation 1 1
Weight Changes 1 1
Obstruction/Occlusion 1 1
Hypoxia 1 1
Pseudoaneurysm 1 1
Feeding Problem 1 1
Pancreatitis 1 1
Dehydration 1 1
Peritonitis 1 1

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