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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
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
M.I. TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 106 106
2020 120 120
2021 106 106
2022 61 61
2023 110 110
2024 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 123 123
Material Deformation 94 94
Adverse Event Without Identified Device or Use Problem 64 64
Break 61 61
Positioning Problem 51 51
Activation Failure 44 44
Positioning Failure 41 41
Migration 27 27
Use of Device Problem 25 25
Appropriate Term/Code Not Available 19 19
Detachment of Device or Device Component 19 19
Failure to Advance 19 19
Material Twisted/Bent 17 17
Leak/Splash 16 16
Difficult to Remove 16 16
Fracture 16 16
Defective Device 15 15
Unraveled Material 14 14
Material Separation 10 10
Obstruction of Flow 9 9
Material Rupture 9 9
Device-Device Incompatibility 9 9
Material Integrity Problem 9 9
Device Dislodged or Dislocated 8 8
Premature Activation 8 8
Difficult or Delayed Positioning 7 7
Difficult to Advance 7 7
Malposition of Device 7 7
Device Stenosis 6 6
Mechanical Problem 6 6
Insufficient Information 5 5
Human-Device Interface Problem 5 5
Expiration Date Error 4 4
Premature Separation 4 4
Migration or Expulsion of Device 4 4
Burst Container or Vessel 4 4
Entrapment of Device 4 4
Complete Blockage 3 3
Loose or Intermittent Connection 3 3
Deformation Due to Compressive Stress 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Separation Failure 2 2
Separation Problem 2 2
No Apparent Adverse Event 2 2
Packaging Problem 2 2
Off-Label Use 2 2
Material Puncture/Hole 2 2
Structural Problem 2 2
Device Slipped 2 2
Contamination 2 2
Material Fragmentation 2 2
Inflation Problem 2 2
Difficult to Insert 1 1
Fluid/Blood Leak 1 1
Disconnection 1 1
Deflation Problem 1 1
Partial Blockage 1 1
Collapse 1 1
Stretched 1 1
Failure to Align 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Unsealed Device Packaging 1 1
Material Split, Cut or Torn 1 1
Ejection Problem 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Unclear Information 1 1
Failure to Fire 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 238 238
No Consequences Or Impact To Patient 113 113
No Information 22 22
Obstruction/Occlusion 18 18
No Known Impact Or Consequence To Patient 18 18
Blood Loss 15 15
Insufficient Information 13 13
Hemorrhage/Bleeding 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
No Code Available 11 11
Death 11 11
Occlusion 11 11
Dyspnea 8 8
No Patient Involvement 8 8
Stenosis 8 8
Thrombosis/Thrombus 6 6
Stenosis of the esophagus 6 6
Restenosis 6 6
Unspecified Infection 6 6
Inflammation 6 6
Thrombosis 6 6
Renal Failure 5 5
Ischemia 5 5
Aneurysm 5 5
Hypoxia 5 5
Embolism 4 4
Pneumothorax 4 4
Device Embedded In Tissue or Plaque 4 4
Discomfort 4 4
Vascular Dissection 3 3
Foreign Body In Patient 3 3
Respiratory Insufficiency 3 3
Foreign Body Embolism 3 3
Perforation 3 3
Hematoma 3 3
Calcium Deposits/Calcification 2 2
Erosion 2 2
Airway Obstruction 2 2
Pneumonia 2 2
Respiratory Distress 2 2
Heart Failure 2 2
Unspecified Kidney or Urinary Problem 2 2
Claudication 2 2
Thromboembolism 2 2
Pseudoaneurysm 2 2
Injury 2 2
Disability 1 1
Laceration(s) of Esophagus 1 1
Respiratory Tract Infection 1 1
Ulcer 1 1
Respiratory Failure 1 1
Ischemic Heart Disease 1 1
Cough 1 1
Swelling/ Edema 1 1
Rupture 1 1
Peritonitis 1 1
Shock 1 1
Thrombus 1 1
Perforation of Vessels 1 1
Pulmonary Edema 1 1
Pain 1 1
Anemia 1 1
Bradycardia 1 1
Encephalopathy 1 1
Fistula 1 1
Granuloma 1 1
Abrasion 1 1
Hemoptysis 1 1
Impotence 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation I May-18-2022
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