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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
Regulation Description Tracheal prosthesis.
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
2020 120 120
2021 106 106
2022 61 61
2023 110 110
2024 77 77
2025 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 138 138
Material Deformation 91 91
Adverse Event Without Identified Device or Use Problem 62 62
Break 49 49
Positioning Failure 43 43
Positioning Problem 42 42
Activation Failure 41 41
Use of Device Problem 26 26
Migration 25 25
Material Twisted/Bent 20 20
Failure to Advance 19 19
Appropriate Term/Code Not Available 19 19
Fracture 14 14
Defective Device 13 13
Leak/Splash 12 12
Difficult to Remove 12 12
Unraveled Material 12 12
Detachment of Device or Device Component 11 11
Material Separation 10 10
Device-Device Incompatibility 9 9
Difficult or Delayed Positioning 9 9
Difficult to Advance 8 8
Malposition of Device 7 7
Material Integrity Problem 7 7
Material Rupture 7 7
Device Stenosis 6 6
Insufficient Information 5 5
Device Dislodged or Dislocated 5 5
Mechanical Problem 5 5
Premature Activation 5 5
Obstruction of Flow 5 5
Premature Separation 4 4
Human-Device Interface Problem 4 4
Unsealed Device Packaging 3 3
Migration or Expulsion of Device 3 3
Difficult to Open or Close 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Deformation Due to Compressive Stress 3 3
Material Puncture/Hole 2 2
Off-Label Use 2 2
Complete Blockage 2 2
Entrapment of Device 2 2
Material Fragmentation 2 2
Packaging Problem 2 2
No Apparent Adverse Event 2 2
Separation Failure 2 2
Expiration Date Error 2 2
Separation Problem 2 2
Wrong Label 2 2
Stretched 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 287 287
No Consequences Or Impact To Patient 67 67
Obstruction/Occlusion 17 17
Hemorrhage/Bleeding 14 14
Insufficient Information 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Blood Loss 10 10
Death 9 9
Occlusion 8 8
Dyspnea 8 8
No Information 8 8
Thrombosis/Thrombus 6 6
Stenosis of the esophagus 6 6
Renal Failure 6 6
Restenosis 6 6
Aneurysm 5 5
Stenosis 5 5
Thrombosis 5 5
No Code Available 5 5
Perforation 5 5
Discomfort 4 4
Embolism 4 4
Ischemia 4 4
Hypoxia 4 4
No Known Impact Or Consequence To Patient 4 4
Unspecified Infection 4 4
Foreign Body Embolism 3 3
Respiratory Insufficiency 3 3
Pneumothorax 3 3
Device Embedded In Tissue or Plaque 3 3
Inflammation 3 3
Claudication 2 2
Pseudoaneurysm 2 2
Injury 2 2
No Patient Involvement 2 2
Thromboembolism 2 2
Foreign Body In Patient 2 2
Vascular Dissection 2 2
Hematoma 2 2
Cardiac Arrest 2 2
Calcium Deposits/Calcification 2 2
Erosion 2 2
Unspecified Kidney or Urinary Problem 2 2
Swelling/ Edema 1 1
Impotence 1 1
Low Blood Pressure/ Hypotension 1 1
Hypersensitivity/Allergic reaction 1 1
Granuloma 1 1
Pneumonia 1 1
Encephalopathy 1 1

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