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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
COOK IRELAND LTD
  SUBSTANTIALLY EQUIVALENT 1
M.I. TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
M.I.TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 70 70
2015 72 72
2016 56 56
2017 49 49
2018 44 44
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
Activation, Positioning or Separation Problem 105 105
Adverse Event Without Identified Device or Use Problem 100 100
Positioning Problem 70 70
Activation Failure 54 54
Premature Activation 52 52
Break 47 47
Material Deformation 36 36
Insufficient Information 33 33
Difficult to Remove 32 32
Migration 25 25
Migration or Expulsion of Device 24 24
Delivery System Failure 21 21
Positioning Failure 16 16
Device Stenosis 12 12
Use of Device Problem 10 10
Improper or Incorrect Procedure or Method 9 9
Difficult or Delayed Positioning 9 9
Detachment of Device or Device Component 8 8
Off-Label Use 7 7
Difficult to Advance 6 6
Obstruction of Flow 6 6
Material Twisted/Bent 5 5
Fracture 5 5
Kinked 4 4
Appropriate Term/Code Not Available 4 4
Material Integrity Problem 4 4
Structural Problem 3 3
Material Perforation 3 3
Bent 3 3
Failure to Advance 3 3
Human-Device Interface Problem 3 3
Occlusion Within Device 3 3
Mechanical Problem 3 3
Activation Problem 3 3
Entrapment of Device 3 3
Unraveled Material 2 2
Defective Device 2 2
Partial Blockage 2 2
Deformation Due to Compressive Stress 2 2
Material Puncture/Hole 2 2
Air Leak 1 1
Device Misassembled During Manufacturing /Shipping 1 1
No Apparent Adverse Event 1 1
Unsealed Device Packaging 1 1
Difficult To Position 1 1
Material Separation 1 1
Detachment Of Device Component 1 1
Device Appears to Trigger Rejection 1 1
No Display/Image 1 1
Material Erosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 207 207
No Clinical Signs, Symptoms or Conditions 107 107
Perforation 92 92
No Known Impact Or Consequence To Patient 67 67
Obstruction/Occlusion 32 32
Bowel Perforation 31 31
Death 27 27
Hemorrhage/Bleeding 19 19
No Code Available 19 19
Abdominal Pain 17 17
Peritonitis 16 16
Pain 13 13
Insufficient Information 10 10
Erosion 9 9
Unspecified Infection 8 8
Occlusion 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Sepsis 6 6
Fistula 5 5
Pneumonia 5 5
Vomiting 5 5
Inflammation 4 4
Failure of Implant 4 4
Foreign Body In Patient 4 4
Pancreatitis 3 3
Ulcer 3 3
Cardiac Arrest 3 3
Discomfort 3 3
Fever 3 3
Restenosis 2 2
Internal Organ Perforation 2 2
Constipation 2 2
Stenosis 2 2
Nausea 2 2
Laceration(s) 2 2
Diarrhea 2 2
Thrombosis/Thrombus 2 2
Burning Sensation 2 2
No Information 2 2
Blood Loss 2 2
Embolism/Embolus 2 2
Migration 1 1
Disability 1 1
Post Traumatic Wound Infection 1 1
Septic Shock 1 1
Urinary Incontinence 1 1
Jaundice 1 1
Alteration in Body Temperature 1 1
Gastrointestinal Hemorrhage 1 1
Disseminated Intravascular Coagulation (DIC) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Aug-31-2010
2 SPS Sterilization, Inc II Sep-13-2018
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