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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stent, metallic, expandable, duodenal
Product CodeMUM
Regulation Number 878.3610
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK IRELAND LTD
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 43 43
2015 51 51
2016 41 41
2017 85 85
2018 49 49
2019 35 35
2020 32 32
2021 70 70
2022 28 28
2023 52 52
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Break 99 99
Fracture 82 82
Activation, Positioning or Separation Problem 81 81
Adverse Event Without Identified Device or Use Problem 72 72
Activation Failure 43 43
Migration 42 42
Migration or Expulsion of Device 37 37
Positioning Problem 37 37
Premature Activation 26 26
Material Deformation 24 24
Delivery System Failure 22 22
Partial Blockage 19 19
Positioning Failure 16 16
Insufficient Information 15 15
Difficult to Remove 15 15
Improper or Incorrect Procedure or Method 11 11
Appropriate Term/Code Not Available 10 10
Detachment of Device or Device Component 7 7
Difficult or Delayed Positioning 7 7
Off-Label Use 6 6
Device Stenosis 5 5
Kinked 5 5
Use of Device Problem 5 5
Difficult to Advance 4 4
Complete Blockage 4 4
Device Damaged Prior to Use 3 3
Defective Device 3 3
Occlusion Within Device 3 3
Material Twisted/Bent 3 3
Obstruction of Flow 3 3
Failure to Advance 2 2
Material Separation 2 2
Structural Problem 2 2
Deformation Due to Compressive Stress 2 2
Unsealed Device Packaging 2 2
Collapse 2 2
Entrapment of Device 2 2
Activation Problem 2 2
Premature Separation 1 1
Packaging Problem 1 1
Device Packaging Compromised 1 1
Material Fragmentation 1 1
Tip breakage 1 1
Unraveled Material 1 1
Material Perforation 1 1
Material Integrity Problem 1 1
Unclear Information 1 1
Delivery System Issue, No Description 1 1
Device Contamination with Chemical or Other Material 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 141 141
No Clinical Signs, Symptoms or Conditions 88 88
No Known Impact Or Consequence To Patient 79 79
Perforation 51 51
Obstruction/Occlusion 46 46
Vomiting 28 28
Hemorrhage/Bleeding 20 20
Death 20 20
Stenosis 14 14
Abdominal Pain 13 13
Erosion 13 13
Inflammation 12 12
No Code Available 11 11
Occlusion 11 11
Insufficient Information 10 10
Pneumonia 8 8
Gastrointestinal Hemorrhage 7 7
Aspiration/Inhalation 7 7
Foreign Body In Patient 7 7
No Information 6 6
Unspecified Infection 5 5
Nausea 4 4
Pain 4 4
Peritonitis 4 4
Bowel Perforation 3 3
Fever 3 3
Constipation 2 2
Feeding Problem 2 2
Reocclusion 2 2
Laceration(s) 2 2
Discomfort 2 2
Thrombosis/Thrombus 2 2
Migration 2 2
Cardiac Arrest 2 2
Anemia 2 2
Abdominal Distention 2 2
Hematoma 2 2
Necrosis 2 2
Pancreatitis 2 2
Blood Loss 1 1
Foreign body, removal of 1 1
No Patient Involvement 1 1
Abscess 1 1
Sepsis 1 1
Surgical procedure, additional 1 1
Dysphagia/ Odynophagia 1 1
Shock 1 1
Failure of Implant 1 1
Hypoxia 1 1
Ulcer 1 1

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