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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 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 59 59
Activation Failure 36 36
Activation, Positioning or Separation Problem 33 33
Positioning Problem 30 30
Premature Activation 29 29
Break 25 25
Migration 23 23
Difficult to Remove 21 21
Material Deformation 18 18
Positioning Failure 12 12
Migration or Expulsion of Device 10 10
Use of Device Problem 10 10
Device Stenosis 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
Obstruction of Flow 5 5
Detachment of Device or Device Component 5 5
Difficult to Advance 5 5
Material Integrity Problem 4 4
Material Twisted/Bent 4 4
Structural Problem 3 3
Entrapment of Device 3 3
Fracture 2 2
Mechanical Problem 2 2
Failure to Advance 2 2
Deformation Due to Compressive Stress 2 2
Material Puncture/Hole 2 2
Activation Problem 2 2
Appropriate Term/Code Not Available 2 2
Human-Device Interface Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Appears to Trigger Rejection 1 1
Unsealed Device Packaging 1 1
No Display/Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 95 95
No Consequences Or Impact To Patient 45 45
Perforation 34 34
Obstruction/Occlusion 26 26
No Known Impact Or Consequence To Patient 23 23
Bowel Perforation 21 21
Hemorrhage/Bleeding 17 17
Abdominal Pain 10 10
Erosion 8 8
Insufficient Information 8 8
No Code Available 7 7
Occlusion 7 7
Pain 7 7
Death 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Fistula 5 5
Unspecified Infection 5 5
Sepsis 5 5
Vomiting 5 5
Peritonitis 4 4
Fever 3 3
Failure of Implant 3 3
Discomfort 3 3
Blood Loss 2 2
Foreign Body In Patient 2 2
No Information 2 2
Constipation 2 2
Thrombosis/Thrombus 2 2
Restenosis 2 2
Cardiac Arrest 2 2
Diarrhea 2 2
Inflammation 2 2
Laceration(s) 2 2
Pneumonia 2 2
Nausea 1 1
Stenosis 1 1
Ulcer 1 1
Burning Sensation 1 1
Septic Shock 1 1
Shock 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Edema 1 1
Emotional Changes 1 1
Abscess 1 1
Aspiration/Inhalation 1 1
Bacterial Infection 1 1
Hematoma 1 1
Low Blood Pressure/ Hypotension 1 1
Gastrointestinal Hemorrhage 1 1
Pancreatitis 1 1
Rectal Anastomotic Leakage 1 1
Alteration in Body Temperature 1 1
Fecal Incontinence 1 1
Urinary Incontinence 1 1
Post Traumatic Wound Infection 1 1
Abdominal Cramps 1 1

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