• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 131 131
Material Deformation 90 90
Adverse Event Without Identified Device or Use Problem 59 59
Break 48 48
Positioning Problem 42 42
Positioning Failure 41 41
Activation Failure 39 39
Use of Device Problem 25 25
Migration 24 24
Appropriate Term/Code Not Available 19 19
Material Twisted/Bent 18 18
Failure to Advance 18 18
Defective Device 13 13
Difficult to Remove 12 12
Unraveled Material 12 12
Leak/Splash 12 12
Fracture 12 12
Detachment of Device or Device Component 11 11
Device-Device Incompatibility 9 9
Difficult or Delayed Positioning 9 9
Material Separation 8 8
Difficult to Advance 8 8
Material Rupture 7 7
Malposition of Device 7 7
Material Integrity Problem 6 6
Device Stenosis 6 6
Mechanical Problem 5 5
Insufficient Information 5 5
Premature Activation 5 5
Device Dislodged or Dislocated 5 5
Obstruction of Flow 5 5
Human-Device Interface Problem 4 4
Premature Separation 4 4
Device Misassembled During Manufacturing /Shipping 3 3
Deformation Due to Compressive Stress 3 3
Migration or Expulsion of Device 3 3
Entrapment of Device 2 2
Wrong Label 2 2
Material Puncture/Hole 2 2
Unsealed Device Packaging 2 2
Separation Problem 2 2
Complete Blockage 2 2
Difficult to Open or Close 2 2
Expiration Date Error 2 2
No Apparent Adverse Event 2 2
Material Fragmentation 2 2
Packaging Problem 2 2
Off-Label Use 2 2
Separation Failure 2 2
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 275 275
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
No Information 8 8
Stenosis of the esophagus 6 6
Thrombosis/Thrombus 6 6
Restenosis 6 6
Renal Failure 6 6
Perforation 5 5
No Code Available 5 5
Stenosis 5 5
Thrombosis 5 5
Aneurysm 5 5
Dyspnea 5 5
Unspecified Infection 4 4
Hypoxia 4 4
Ischemia 4 4
Embolism 4 4
No Known Impact Or Consequence To Patient 4 4
Discomfort 4 4
Inflammation 3 3
Foreign Body Embolism 3 3
Respiratory Insufficiency 3 3
Pneumothorax 3 3
Device Embedded In Tissue or Plaque 3 3
Erosion 2 2
Vascular Dissection 2 2
Pseudoaneurysm 2 2
No Patient Involvement 2 2
Claudication 2 2
Calcium Deposits/Calcification 2 2
Thromboembolism 2 2
Unspecified Kidney or Urinary Problem 2 2
Hematoma 2 2
Injury 2 2
Foreign Body In Patient 2 2
Cardiac Arrest 2 2
Hypersensitivity/Allergic reaction 1 1
Airway Obstruction 1 1
Pulmonary Edema 1 1
Pneumonia 1 1
Low Blood Pressure/ Hypotension 1 1
Anemia 1 1
Heart Failure 1 1

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