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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
M.I. TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2018 122 122
2019 106 106
2020 120 120
2021 106 106
2022 62 62
2023 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 88 88
Material Deformation 71 71
Activation, Positioning or Separation Problem 70 70
Break 59 59
Positioning Problem 56 56
Activation Failure 43 43
Positioning Failure 32 32
Migration 22 22
Appropriate Term/Code Not Available 22 22
Difficult to Remove 19 19
Detachment of Device or Device Component 18 18
Leak/Splash 17 17
Unraveled Material 17 17
Obstruction of Flow 13 13
Failure to Advance 12 12
Fracture 11 11
Use of Device Problem 10 10
Material Rupture 9 9
Material Separation 9 9
Premature Activation 9 9
Defective Device 9 9
Insufficient Information 9 9
Material Integrity Problem 8 8
Material Twisted/Bent 8 8
Device-Device Incompatibility 8 8
Migration or Expulsion of Device 8 8
Difficult to Advance 7 7
Deformation Due to Compressive Stress 7 7
Device Dislodged or Dislocated 7 7
Difficult or Delayed Positioning 6 6
Human-Device Interface Problem 5 5
Expiration Date Error 4 4
Burst Container or Vessel 4 4
Complete Blockage 4 4
Loose or Intermittent Connection 4 4
Mechanical Problem 4 4
Material Puncture/Hole 3 3
Contamination 3 3
Entrapment of Device 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Component Missing 3 3
Packaging Problem 2 2
Difficult to Open or Close 2 2
Separation Failure 2 2
Structural Problem 2 2
Failure to Align 2 2
Failure to Fire 2 2
Fluid/Blood Leak 2 2
Material Fragmentation 2 2
Inflation Problem 2 2
Failure to Capture 2 2
Device Slipped 2 2
Separation Problem 2 2
Premature Separation 2 2
Unclear Information 1 1
Stretched 1 1
Inadequacy of Device Shape and/or Size 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Unstable 1 1
Retraction Problem 1 1
Occlusion Within Device 1 1
Unsealed Device Packaging 1 1
Collapse 1 1
Deflation Problem 1 1
Partial Blockage 1 1
Difficult to Insert 1 1
Hole In Material 1 1
Disconnection 1 1
Wrinkled 1 1
Malposition of Device 1 1
Blocked Connection 1 1
Device Operates Differently Than Expected 1 1
Component or Accessory Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Infusion or Flow Problem 1 1
Material Protrusion/Extrusion 1 1
No Apparent Adverse Event 1 1
Material Split, Cut or Torn 1 1
Ejection Problem 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 158 158
No Clinical Signs, Symptoms or Conditions 122 122
Blood Loss 28 28
Death 27 27
No Information 26 26
No Known Impact Or Consequence To Patient 24 24
Thrombosis 23 23
Renal Failure 21 21
Occlusion 19 19
No Code Available 17 17
Hemorrhage/Bleeding 15 15
Obstruction/Occlusion 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
No Patient Involvement 10 10
Ischemia 9 9
Insufficient Information 9 9
Aneurysm 8 8
Dyspnea 7 7
Hematoma 7 7
Vascular Dissection 7 7
Thrombosis/Thrombus 6 6
Restenosis 6 6
Stenosis 5 5
Embolism 5 5
Unspecified Infection 5 5
Inflammation 5 5
Discomfort 4 4
Injury 4 4
Respiratory Failure 4 4
Pseudoaneurysm 4 4
Device Embedded In Tissue or Plaque 4 4
Foreign Body In Patient 4 4
Claudication 3 3
Thrombus 3 3
Pain 3 3
Perforation 3 3
Pneumothorax 3 3
Arrhythmia 3 3
Airway Obstruction 3 3
Calcium Deposits/Calcification 2 2
Granuloma 2 2
Pulmonary Edema 2 2
Respiratory Distress 2 2
Pneumonia 2 2
Hypoxia 2 2
Heart Failure 2 2
Unspecified Kidney or Urinary Problem 2 2
Pericardial Effusion 2 2
Foreign Body Embolism 2 2
Patient Problem/Medical Problem 2 2
Thromboembolism 2 2
Test Result 1 1
Cough 1 1
Respiratory Insufficiency 1 1
Rupture 1 1
Peritonitis 1 1
Disability 1 1
Reaction 1 1
Loss of consciousness 1 1
Respiratory Tract Infection 1 1
Jaundice 1 1
Aortic Dissection 1 1
Ischemic Heart Disease 1 1
Failure of Implant 1 1
Impotence 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Myocardial Infarction 1 1
Nerve Damage 1 1
Internal Organ Perforation 1 1
Abrasion 1 1
Hemoptysis 1 1
Embolus 1 1
Encephalopathy 1 1
Fistula 1 1
Bone Fracture(s) 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1
Anemia 1 1
Aspiration/Inhalation 1 1
Bradycardia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation I May-18-2022
2 SPS Sterilization, Inc II Sep-13-2018
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