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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
M.I. TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
M.I.TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 42 42
2020 46 46
2021 56 56
2022 35 35
2023 38 38
2024 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 64 64
Activation Failure 37 37
Activation, Positioning or Separation Problem 35 35
Positioning Problem 32 32
Premature Activation 29 29
Break 27 27
Migration 25 25
Material Deformation 23 23
Difficult to Remove 21 21
Positioning Failure 14 14
Device Stenosis 12 12
Migration or Expulsion of Device 10 10
Use of Device Problem 10 10
Difficult or Delayed Positioning 9 9
Improper or Incorrect Procedure or Method 8 8
Insufficient Information 8 8
Off-Label Use 7 7
Difficult to Advance 6 6
Material Twisted/Bent 5 5
Obstruction of Flow 5 5
Detachment of Device or Device Component 5 5
Material Integrity Problem 4 4
Activation Problem 3 3
Entrapment of Device 3 3
Failure to Advance 3 3
Human-Device Interface Problem 3 3
Structural Problem 3 3
Mechanical Problem 2 2
Appropriate Term/Code Not Available 2 2
Fracture 2 2
Deformation Due to Compressive Stress 2 2
Material Puncture/Hole 2 2
No Display/Image 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Defective Device 1 1
Unsealed Device Packaging 1 1
Device Appears to Trigger Rejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 107 107
No Consequences Or Impact To Patient 45 45
Perforation 35 35
Obstruction/Occlusion 31 31
Bowel Perforation 23 23
No Known Impact Or Consequence To Patient 23 23
Hemorrhage/Bleeding 19 19
Abdominal Pain 10 10
Insufficient Information 10 10
Erosion 8 8
No Code Available 7 7
Occlusion 7 7
Pain 7 7
Unspecified Infection 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Death 6 6
Sepsis 6 6
Fistula 5 5
Pneumonia 5 5
Vomiting 5 5
Peritonitis 4 4
Pancreatitis 3 3
Failure of Implant 3 3
Inflammation 3 3
Discomfort 3 3
Cardiac Arrest 3 3
Fever 3 3
Restenosis 2 2
Constipation 2 2
Laceration(s) 2 2
Diarrhea 2 2
Thrombosis/Thrombus 2 2
Foreign Body In Patient 2 2
Blood Loss 2 2
Embolism/Embolus 2 2
No Information 2 2
Burning Sensation 1 1
Post Traumatic Wound Infection 1 1
Edema 1 1
Alteration in Body Temperature 1 1
Hematoma 1 1
Septic Shock 1 1
Jaundice 1 1
Aspiration/Inhalation 1 1
Abdominal Cramps 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Abscess 1 1
Fecal Incontinence 1 1
Stenosis 1 1
Shock 1 1

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