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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device stent, colonic, metallic, expandable
Regulation Description Esophageal prosthesis.
Product CodeMQR
Regulation Number 878.3610
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 46 46
2021 56 56
2022 35 35
2023 38 38
2024 72 72
2025 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 64 64
Material Deformation 33 33
Positioning Problem 30 30
Activation Failure 29 29
Activation, Positioning or Separation Problem 28 28
Migration 26 26
Break 24 24
Premature Activation 24 24
Difficult to Remove 20 20
Positioning Failure 18 18
Device Stenosis 13 13
Use of Device Problem 12 12
Material Twisted/Bent 10 10
Migration or Expulsion of Device 9 9
Insufficient Information 8 8
Improper or Incorrect Procedure or Method 8 8
Material Integrity Problem 7 7
Difficult or Delayed Positioning 7 7
Off-Label Use 6 6
Difficult to Advance 6 6
Detachment of Device or Device Component 5 5
Obstruction of Flow 4 4
Failure to Advance 4 4
Entrapment of Device 3 3
Activation Problem 3 3
Structural Problem 3 3
Human-Device Interface Problem 3 3
Deformation Due to Compressive Stress 3 3
Mechanical Problem 2 2
Material Puncture/Hole 2 2
Appropriate Term/Code Not Available 2 2
No Display/Image 1 1
Unsealed Device Packaging 1 1
Defective Device 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Dent in Material 1 1
Material Perforation 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 124 124
Perforation 30 30
Obstruction/Occlusion 28 28
No Consequences Or Impact To Patient 27 27
Hemorrhage/Bleeding 22 22
Bowel Perforation 20 20
No Known Impact Or Consequence To Patient 12 12
Insufficient Information 10 10
Abdominal Pain 7 7
Erosion 7 7
Occlusion 7 7
Unspecified Infection 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Sepsis 6 6
Pain 6 6
Vomiting 6 6
Fistula 5 5
No Code Available 5 5
Pneumonia 5 5
Discomfort 3 3
Fever 3 3
Cardiac Arrest 3 3
Inflammation 3 3
Pancreatitis 3 3
Embolism/Embolus 2 2
Blood Loss 2 2
Peritonitis 2 2
Foreign Body In Patient 2 2
Thrombosis/Thrombus 2 2
Diarrhea 2 2
No Information 2 2
Nausea 2 2
Laceration(s) 2 2
Stenosis 2 2
Unspecified Tissue Injury 2 2
Constipation 2 2
Restenosis 2 2
Edema 1 1
Hematoma 1 1
Post Traumatic Wound Infection 1 1
Aspiration/Inhalation 1 1
Incontinence 1 1
Abdominal Cramps 1 1
Burning Sensation 1 1
Fecal Incontinence 1 1
Rectal Anastomotic Leakage 1 1
Alteration in Body Temperature 1 1
Septic Shock 1 1
Jaundice 1 1
Disseminated Intravascular Coagulation (DIC) 1 1

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