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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 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 97 97
Activation, Positioning or Separation Problem 81 81
Fracture 80 80
Adverse Event Without Identified Device or Use Problem 70 70
Activation Failure 40 40
Migration 39 39
Migration or Expulsion of Device 37 37
Positioning Problem 35 35
Premature Activation 26 26
Delivery System Failure 22 22
Material Deformation 21 21
Partial Blockage 19 19
Positioning Failure 16 16
Insufficient Information 15 15
Difficult to Remove 14 14
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
Kinked 5 5
Use of Device Problem 5 5
Difficult to Advance 4 4
Complete Blockage 4 4
Device Stenosis 4 4
Occlusion Within Device 3 3
Device Damaged Prior to Use 3 3
Obstruction of Flow 3 3
Defective Device 3 3
Failure to Advance 2 2
Unsealed Device Packaging 2 2
Material Separation 2 2
Entrapment of Device 2 2
Material Twisted/Bent 2 2
Activation Problem 2 2
Premature Separation 1 1
Unclear Information 1 1
Physical Resistance/Sticking 1 1
Material Integrity Problem 1 1
Packaging Problem 1 1
Material Fragmentation 1 1
Material Frayed 1 1
Collapse 1 1
Tip breakage 1 1
Unraveled Material 1 1
Retraction Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Device Operates Differently Than Expected 1 1
Device Packaging Compromised 1 1
Delivery System Issue, No Description 1 1
Deformation Due to Compressive Stress 1 1
Structural Problem 1 1
Material Perforation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 141 141
No Known Impact Or Consequence To Patient 79 79
No Clinical Signs, Symptoms or Conditions 77 77
Perforation 49 49
Obstruction/Occlusion 46 46
Vomiting 28 28
Death 20 20
Hemorrhage/Bleeding 18 18
Stenosis 14 14
Erosion 13 13
Abdominal Pain 12 12
Inflammation 12 12
Occlusion 11 11
No Code Available 11 11
Insufficient Information 10 10
Foreign Body In Patient 7 7
Pneumonia 7 7
Aspiration/Inhalation 6 6
No Information 6 6
Gastrointestinal Hemorrhage 6 6
Unspecified Infection 5 5
Pain 4 4
Nausea 4 4
Peritonitis 4 4
Bowel Perforation 3 3
Fever 3 3
Hematoma 2 2
Anemia 2 2
Feeding Problem 2 2
Cardiac Arrest 2 2
Necrosis 2 2
Laceration(s) 2 2
Reocclusion 2 2
Migration 2 2
Constipation 2 2
Thrombosis/Thrombus 2 2
Discomfort 2 2
Abdominal Distention 2 2
Pancreatitis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Weight Changes 1 1
No Patient Involvement 1 1
Surgical procedure, additional 1 1
Blood Loss 1 1
Foreign body, removal of 1 1
Ulcer 1 1
Aspiration Pneumonitis 1 1
Device Embedded In Tissue or Plaque 1 1
Dysphasia 1 1
Sepsis 1 1
Shock 1 1
Dysphagia/ Odynophagia 1 1
Bacterial Infection 1 1
Air Embolism 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Failure of Implant 1 1

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