• 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 stent, carotid
Definition Stent, Carotid -- a metal scaffold placed via a delivery catheter into the carotid artery to maintain the lumen
Product CodeNIM
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
11 7 13 17 14 7

MDR Year MDR Reports MDR Events
2019 181 181
2020 163 163
2021 201 201
2022 172 172
2023 172 172
2024 100 100

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 310 310
Activation, Positioning or Separation Problem 108 108
Difficult or Delayed Positioning 101 101
Material Deformation 80 80
Difficult to Advance 54 54
Activation Failure 54 54
Premature Activation 53 53
Difficult to Remove 51 51
Break 51 51
Detachment of Device or Device Component 47 47
Positioning Failure 44 44
Material Separation 44 44
Fracture 24 24
Entrapment of Device 23 23
Failure to Advance 21 21
Malposition of Device 21 21
Mechanical Problem 20 20
Mechanical Jam 19 19
Migration 12 12
Positioning Problem 12 12
Defective Device 12 12
Physical Resistance/Sticking 11 11
Deformation Due to Compressive Stress 10 10
Device Dislodged or Dislocated 9 9
Material Split, Cut or Torn 9 9
Material Integrity Problem 8 8
Device Contamination with Chemical or Other Material 7 7
Difficult or Delayed Activation 7 7
Migration or Expulsion of Device 7 7
Crack 6 6
Difficult to Insert 6 6
Improper or Incorrect Procedure or Method 5 5
Material Frayed 5 5
Device-Device Incompatibility 5 5
Patient-Device Incompatibility 5 5
Loss of or Failure to Bond 4 4
Use of Device Problem 4 4
Leak/Splash 4 4
Off-Label Use 4 4
Tear, Rip or Hole in Device Packaging 3 3
Unsealed Device Packaging 3 3
Difficult to Open or Remove Packaging Material 3 3
Activation Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Component Missing 2 2
Device Markings/Labelling Problem 2 2
Device Damaged by Another Device 2 2
Contamination 2 2
Difficult to Flush 2 2
Obstruction of Flow 2 2
Loose or Intermittent Connection 2 2
Device Difficult to Setup or Prepare 2 2
Unclear Information 2 2
Appropriate Term/Code Not Available 2 2
Poor Visibility 1 1
Material Puncture/Hole 1 1
Retraction Problem 1 1
Defective Component 1 1
Stretched 1 1
Collapse 1 1
Accessory Incompatible 1 1
Partial Blockage 1 1
Peeled/Delaminated 1 1
Ambient Temperature Problem 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Unintended Movement 1 1
Material Twisted/Bent 1 1
Difficult to Open or Close 1 1
Inaccurate Information 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 398 398
No Consequences Or Impact To Patient 180 180
Thrombosis/Thrombus 113 113
Stroke/CVA 95 95
Ischemia Stroke 70 70
Transient Ischemic Attack 40 40
Patient Problem/Medical Problem 36 36
Stenosis 35 35
Vascular Dissection 30 30
Myocardial Infarction 28 28
Obstruction/Occlusion 27 27
Low Blood Pressure/ Hypotension 23 23
Restenosis 23 23
Thrombosis 21 21
No Patient Involvement 19 19
Insufficient Information 17 17
Hematoma 16 16
Foreign Body In Patient 16 16
Brain Injury 16 16
Bradycardia 15 15
Occlusion 14 14
No Known Impact Or Consequence To Patient 13 13
Pain 12 12
Intracranial Hemorrhage 11 11
Thrombus 10 10
Embolism/Embolus 9 9
Unspecified Tissue Injury 9 9
Death 8 8
Dysphasia 8 8
Embolism 8 8
Blood Loss 8 8
Renal Failure 7 7
Arrhythmia 7 7
Muscle Weakness 6 6
Hemorrhage/Bleeding 6 6
High Blood Pressure/ Hypertension 6 6
Dizziness 5 5
Device Embedded In Tissue or Plaque 5 5
Vasoconstriction 4 4
Speech Disorder 4 4
Neurological Deficit/Dysfunction 4 4
Ischemia 4 4
Extravasation 4 4
Perforation of Vessels 4 4
Reocclusion 4 4
Nervous System Injury 4 4
Paresis 4 4
Convulsion/Seizure 3 3
Seizures 3 3
Hemorrhagic Stroke 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Swelling/ Edema 3 3
Unspecified Nervous System Problem 3 3
Pseudoaneurysm 3 3
Rupture 3 3
Aneurysm 3 3
Neck Pain 3 3
Perforation 3 3
Paralysis 3 3
Cardiac Arrest 3 3
Headache 3 3
Unspecified Infection 3 3
Injury 3 3
Chest Pain 2 2
Nerve Damage 2 2
Air Embolism 2 2
No Information 2 2
Loss of Vision 2 2
Infarction, Cerebral 2 2
Thromboembolism 2 2
Hypersensitivity/Allergic reaction 2 2
Prolapse 2 2
Weakness 2 2
Inflammation 2 2
Tissue Damage 2 2
Visual Impairment 2 2
Confusion/ Disorientation 2 2
No Code Available 1 1
Heart Failure 1 1
Hemorrhage, Cerebral 1 1
Atrial Flutter 1 1
Pulmonary Embolism 1 1
Cerebral Hyperperfusion Syndrome 1 1
Syncope 1 1
Angina 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Coma 1 1
Sepsis 1 1
Failure of Implant 1 1
Retroperitoneal Hemorrhage 1 1
Loss of consciousness 1 1
Hypoxia 1 1
Great Vessel Perforation 1 1
Visual Disturbances 1 1
Fever 1 1
Rash 1 1
Vessel Or Plaque, Device Embedded In 1 1
Numbness 1 1
Abdominal Distention 1 1
Purulent Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health Inc. II Dec-20-2019
2 Cordis Corporation I Mar-15-2021
3 Silk Road Medical Inc II Feb-23-2021
-
-