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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, tracheal, expandable
Product CodeJCT
Regulation Number 878.3720
Device Class 2


Premarket Reviews
ManufacturerDecision
ALVEOLUS, INC
  SE - WITH LIMITATIONS 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ENDOCHOICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
M.I. TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 168 168
2015 251 251
2016 217 217
2017 109 109
2018 122 122
2019 106 106
2020 120 120
2021 106 106
2022 61 61
2023 110 110
2024 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 294 294
Adverse Event Without Identified Device or Use Problem 119 119
Positioning Problem 113 113
Break 108 108
Material Deformation 107 107
Activation Failure 86 86
Positioning Failure 64 64
Device Dislodged or Dislocated 63 63
Detachment Of Device Component 56 56
Difficult to Remove 54 54
Migration or Expulsion of Device 52 52
Insufficient Information 38 38
Failure to Advance 37 37
Detachment of Device or Device Component 34 34
Fracture 32 32
Leak/Splash 31 31
Migration 30 30
Appropriate Term/Code Not Available 29 29
Material Separation 28 28
Malposition of Device 25 25
Use of Device Problem 24 24
Premature Activation 23 23
Unraveled Material 22 22
Occlusion Within Device 20 20
Device Operates Differently Than Expected 19 19
Device Slipped 18 18
Material Integrity Problem 17 17
Difficult to Advance 16 16
Material Rupture 16 16
Burst Container or Vessel 16 16
Difficult or Delayed Positioning 16 16
Sticking 15 15
Obstruction of Flow 15 15
Physical Resistance 15 15
Defective Device 15 15
Loose or Intermittent Connection 14 14
Material Twisted/Bent 14 14
Device-Device Incompatibility 10 10
Deflation Problem 10 10
Bent 10 10
Inflation Problem 9 9
Difficult to Insert 9 9
Mechanical Problem 8 8
Entrapment of Device 8 8
Deformation Due to Compressive Stress 8 8
Human-Device Interface Problem 7 7
Kinked 7 7
Component Falling 6 6
Device Stenosis 6 6
Component Missing 5 5
Retraction Problem 5 5
Improper or Incorrect Procedure or Method 4 4
Expiration Date Error 4 4
Complete Blockage 4 4
Premature Separation 4 4
Separation Failure 4 4
Failure to Align 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Packaging Problem 3 3
Collapse 3 3
Disconnection 3 3
Contamination 3 3
Material Fragmentation 3 3
Hole In Material 3 3
Fitting Problem 3 3
Device Damaged Prior to Use 3 3
Inadequacy of Device Shape and/or Size 3 3
Material Puncture/Hole 3 3
Fluid/Blood Leak 2 2
Off-Label Use 2 2
Material Too Rigid or Stiff 2 2
Material Perforation 2 2
Structural Problem 2 2
Failure to Fire 2 2
Crack 2 2
Partial Blockage 2 2
Failure to Capture 2 2
Pressure Problem 2 2
Torn Material 2 2
Unintended Movement 2 2
No Apparent Adverse Event 2 2
Mechanical Jam 2 2
Device Markings/Labelling Problem 2 2
Difficult to Open or Close 2 2
Device Contamination with Chemical or Other Material 2 2
Separation Problem 2 2
Unclear Information 1 1
Material Split, Cut or Torn 1 1
Ejection Problem 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Device Contamination With Biological Material 1 1
Component or Accessory Incompatibility 1 1
Connection Problem 1 1
Folded 1 1
Patient-Device Incompatibility 1 1
Blocked Connection 1 1
No Flow 1 1
Material Protrusion/Extrusion 1 1
Incorrect Device Or Component Shipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 545 545
No Clinical Signs, Symptoms or Conditions 221 221
No Known Impact Or Consequence To Patient 128 128
No Information 123 123
No Code Available 41 41
Death 40 40
Hemorrhage/Bleeding 34 34
Occlusion 34 34
Thrombosis 32 32
Blood Loss 29 29
Stenosis 24 24
Renal Failure 23 23
Obstruction/Occlusion 20 20
No Patient Involvement 20 20
Ischemia 14 14
Foreign Body In Patient 13 13
Insufficient Information 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Vascular Dissection 12 12
Hematoma 10 10
Aneurysm 10 10
Dyspnea 10 10
Embolism 7 7
Unspecified Infection 7 7
Inflammation 7 7
Rupture 7 7
Perforation of Vessels 7 7
Device Embedded In Tissue or Plaque 7 7
Claudication 7 7
Thrombosis/Thrombus 6 6
Stenosis of the esophagus 6 6
Restenosis 6 6
Thrombus 6 6
Perforation 6 6
Pneumonia 6 6
Pneumothorax 5 5
Injury 5 5
Hypoxia 5 5
Cancer 5 5
Discomfort 4 4
Complaint, Ill-Defined 4 4
Pseudoaneurysm 4 4
Hemoptysis 4 4
Fistula 4 4
Airway Obstruction 4 4
Respiratory Failure 4 4
Myocardial Infarction 4 4
Tissue Damage 4 4
Pain 3 3
Arrhythmia 3 3
Erosion 3 3
Calcium Deposits/Calcification 3 3
Stroke/CVA 3 3
Foreign Body Embolism 3 3
Respiratory Insufficiency 3 3
Unspecified Kidney or Urinary Problem 2 2
Thromboembolism 2 2
Vascular System (Circulation), Impaired 2 2
Pericardial Effusion 2 2
Patient Problem/Medical Problem 2 2
Granuloma 2 2
Failure of Implant 2 2
Laceration(s) 2 2
Bradycardia 2 2
Embolus 2 2
Low Blood Pressure/ Hypotension 2 2
Respiratory Distress 2 2
Pulmonary Edema 2 2
Disability 2 2
Heart Failure 2 2
Vomiting 1 1
Jaundice 1 1
Cardiac Tamponade 1 1
Peritonitis 1 1
Ulcer 1 1
Laceration(s) of Esophagus 1 1
Reaction 1 1
Loss of consciousness 1 1
Respiratory Tract Infection 1 1
Aortic Dissection 1 1
Ischemic Heart Disease 1 1
Nerve Damage 1 1
Reocclusion 1 1
Internal Organ Perforation 1 1
Scarring 1 1
Sepsis 1 1
Shock 1 1
Therapeutic Effects, Unexpected 1 1
Encephalopathy 1 1
Exsanguination 1 1
Asphyxia 1 1
Fever 1 1
Cardiac Arrest 1 1
Aspiration/Inhalation 1 1
Atherosclerosis 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Anemia 1 1
Abdominal Pain 1 1
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation I May-18-2022
2 Atrium Medical Corporation II Jul-07-2017
3 Boston Scientific Corporation II Apr-25-2016
4 Boston Scientific Corporation II Jul-15-2011
5 Boston Scientific Corporation II Aug-31-2010
6 Boston Scientific Corporation II Jun-25-2010
7 EXP Pharmaceutical Services Corp II Jul-24-2015
8 SPS Sterilization, Inc II Sep-13-2018
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