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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, esophageal
Product CodeESW
Regulation Number 878.3610
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K211960  Agile Esophageal OTW Stent System
  2.  K233837  Agile Esophageal Stent System
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
  1.  K211960  Agile Esophageal OTW Stent System
  2.  K233837  Agile Esophageal Stent System
M.I. TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
M.I.TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THORACENT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 167 167
2020 155 155
2021 77 77
2022 109 109
2023 152 152
2024 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 185 185
Activation Failure 136 136
Migration 116 116
Adverse Event Without Identified Device or Use Problem 97 97
Activation Problem 70 70
Positioning Problem 55 55
Break 49 49
Material Deformation 49 49
Use of Device Problem 47 47
Improper or Incorrect Procedure or Method 44 44
Detachment of Device or Device Component 38 38
Difficult to Remove 32 32
Positioning Failure 31 31
Off-Label Use 26 26
Failure to Advance 23 23
Appropriate Term/Code Not Available 21 21
Migration or Expulsion of Device 20 20
Insufficient Information 19 19
Material Integrity Problem 17 17
Material Twisted/Bent 13 13
Physical Resistance/Sticking 12 12
Obstruction of Flow 11 11
Difficult or Delayed Positioning 10 10
Fracture 9 9
Material Perforation 8 8
Premature Activation 7 7
Human-Device Interface Problem 7 7
Structural Problem 5 5
Device Stenosis 5 5
Material Separation 4 4
Difficult to Advance 4 4
Device Markings/Labelling Problem 3 3
Unsealed Device Packaging 3 3
Device-Device Incompatibility 3 3
Infusion or Flow Problem 3 3
Material Split, Cut or Torn 2 2
Component Missing 2 2
Unraveled Material 2 2
Wrong Label 2 2
Material Erosion 2 2
Entrapment of Device 2 2
Difficult to Insert 2 2
Sharp Edges 2 2
Packaging Problem 2 2
Fluid/Blood Leak 1 1
Defective Device 1 1
Separation Problem 1 1
Malposition of Device 1 1
Difficult or Delayed Activation 1 1
Dent in Material 1 1
Reflux within Device 1 1
Separation Failure 1 1
Misassembled 1 1
Failure to Deliver 1 1
Loss of or Failure to Bond 1 1
No Apparent Adverse Event 1 1
Deformation Due to Compressive Stress 1 1
Device Dislodged or Dislocated 1 1
Defective Component 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 321 321
No Consequences Or Impact To Patient 139 139
No Known Impact Or Consequence To Patient 43 43
Obstruction/Occlusion 42 42
No Code Available 39 39
Dysphagia/ Odynophagia 36 36
Hemorrhage/Bleeding 22 22
Pain 22 22
Perforation 17 17
Erosion 14 14
Insufficient Information 14 14
Fistula 11 11
Pneumonia 10 10
Vomiting 9 9
Dysphasia 9 9
Discomfort 8 8
Failure of Implant 7 7
Nausea 7 7
Occlusion 7 7
Chest Pain 7 7
Death 7 7
No Information 7 7
Blood Loss 6 6
Regurgitation 5 5
Abdominal Pain 5 5
Aspiration/Inhalation 5 5
Fever 5 5
Perforation of Esophagus 5 5
Foreign Body In Patient 4 4
Gastrointestinal Hemorrhage 4 4
Cough 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Ulcer 3 3
Injury 3 3
Laceration(s) of Esophagus 3 3
Excessive Tear Production 2 2
Peritonitis 2 2
Airway Obstruction 2 2
Dyspnea 2 2
Decreased Appetite 2 2
Difficulty Chewing 2 2
Skin Tears 1 1
Device Embedded In Tissue or Plaque 1 1
Hematemesis 1 1
Anemia 1 1
Arrhythmia 1 1
Abscess 1 1
Pyrosis/Heartburn 1 1
Laceration(s) 1 1
Pulmonary Dysfunction 1 1
Tissue Damage 1 1
Ulceration 1 1
Weight Changes 1 1
No Patient Involvement 1 1
Intraoperative Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Taewoong Medical Co., Ltd. II Feb-14-2020
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