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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
2017 109 109
2018 122 122
2019 106 106
2020 120 120
2021 106 106
2022 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 88 88
Activation, Positioning or SeparationProblem 75 75
Material Deformation 68 68
Break 64 64
Positioning Problem 59 59
Activation Failure 52 52
Positioning Failure 32 32
Appropriate Term/Code Not Available 24 24
Migration 22 22
Difficult to Remove 20 20
Unraveled Material 19 19
Leak/Splash 18 18
Migration or Expulsion of Device 17 17
Fracture 17 17
Detachment of Device or Device Component 17 17
Obstruction of Flow 13 13
Failure to Advance 12 12
Material Separation 12 12
Premature Activation 11 11
Device Dislodged or Dislocated 11 11
Material Rupture 10 10
Insufficient Information 10 10
Detachment Of Device Component 9 9
Material Integrity Problem 8 8
Defective Device 8 8
Use of Device Problem 7 7
Difficult to Advance 7 7
Deformation Due to Compressive Stress 7 7
Burst Container or Vessel 6 6
Difficult or Delayed Positioning 6 6
Loose or Intermittent Connection 5 5
Entrapment of Device 5 5
Device Operates Differently Than Expected 5 5
Human-Device Interface Problem 5 5
Device Slipped 4 4
Expiration Date Error 4 4
Complete Blockage 4 4
Material Twisted/Bent 4 4
Material Fragmentation 3 3
Hole In Material 3 3
Inflation Problem 3 3
Contamination 3 3
Mechanical Problem 3 3
Occlusion Within Device 3 3
Material Puncture/Hole 3 3
Malposition of Device 3 3
Component Missing 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Device-Device Incompatibility 2 2
Difficult to Open or Close 2 2
Improper or Incorrect Procedure or Method 2 2
Structural Problem 2 2
Failure to Align 2 2
Retraction Problem 2 2
Fluid Leak 2 2
Difficult to Insert 2 2
Kinked 2 2
Collapse 2 2
Component Falling 2 2
Failure to Capture 2 2
Bent 2 2
Partial Blockage 2 2
Packaging Problem 2 2
Mechanical Jam 1 1
Material Split, Cut or Torn 1 1
Ejection Problem 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Separation Problem 1 1
Unclear Information 1 1
Deflation Problem 1 1
Disconnection 1 1
Unsealed Device Packaging 1 1
Nonstandard Device 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Damaged Prior to Use 1 1
Stretched 1 1
Unstable 1 1
Blocked Connection 1 1
Failure to Fire 1 1
Wrinkled 1 1
Separation Failure 1 1
Physical Resistance 1 1
Device Contamination with Chemical or Other Material 1 1
Infusion or Flow Problem 1 1
Material Protrusion/Extrusion 1 1
Component or Accessory Incompatibility 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 221 221
No Clinical Signs, Symptoms or Conditions 94 94
No Known Impact Or Consequence To Patient 36 36
No Information 36 36
Death 29 29
Blood Loss 28 28
Renal Failure 23 23
Thrombosis 23 23
Occlusion 22 22
No Code Available 20 20
Hemorrhage/Bleeding 15 15
No Patient Involvement 14 14
Obstruction/Occlusion 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Stenosis 9 9
Ischemia 9 9
Dyspnea 8 8
Aneurysm 8 8
Foreign Body In Patient 8 8
Insufficient Information 8 8
Vascular Dissection 7 7
Hematoma 7 7
Unspecified Infection 6 6
Restenosis 6 6
Thrombosis/Thrombus 6 6
Inflammation 5 5
Embolism 5 5
Device Embedded In Tissue or Plaque 5 5
Pseudoaneurysm 4 4
Discomfort 4 4
Injury 4 4
Respiratory Failure 4 4
Thrombus 4 4
Airway Obstruction 4 4
Pneumothorax 4 4
Pain 3 3
Perforation 3 3
Arrhythmia 3 3
Claudication 3 3
Unspecified Kidney or Urinary Problem 2 2
Calcium Deposits/Calcification 2 2
Pneumonia 2 2
Pulmonary Edema 2 2
Hypoxia 2 2
Failure of Implant 2 2
Heart Failure 2 2
Respiratory Distress 2 2
Patient Problem/Medical Problem 2 2
Thromboembolism 2 2
Pericardial Effusion 2 2
Foreign Body Embolism 1 1
Test Result 1 1
Rupture 1 1
Cardiac Tamponade 1 1
Peritonitis 1 1
Perforation of Vessels 1 1
Vomiting 1 1
Jaundice 1 1
Aortic Dissection 1 1
Ischemic Heart Disease 1 1
Disability 1 1
Reaction 1 1
Loss of consciousness 1 1
Respiratory Tract Infection 1 1
Impotence 1 1
Hemoptysis 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
Cardiac Arrest 1 1
Stroke/CVA 1 1
Abrasion 1 1
Aspiration/Inhalation 1 1
Bradycardia 1 1
Embolus 1 1
Encephalopathy 1 1
Fistula 1 1
Bone Fracture(s) 1 1
Granuloma 1 1
Cough 1 1
Respiratory Insufficiency 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 SPS Sterilization, Inc II Sep-13-2018
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