• 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)
2020 2021 2022 2023 2024 2025
7 13 17 14 21 9

MDR Year MDR Reports MDR Events
2020 163 163
2021 201 201
2022 172 172
2023 172 172
2024 265 265
2025 186 186

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 352 352
Activation, Positioning or Separation Problem 149 149
Difficult or Delayed Positioning 109 109
Material Deformation 97 97
Difficult to Remove 70 70
Break 69 69
Activation Failure 62 62
Difficult to Advance 61 61
Premature Activation 59 59
Positioning Failure 52 52
Detachment of Device or Device Component 41 41
Entrapment of Device 40 40
Material Separation 38 38
Mechanical Problem 30 30
Fracture 28 28
Failure to Advance 22 22
Positioning Problem 22 22
Defective Device 20 20
Malposition of Device 18 18
Mechanical Jam 18 18
Device Markings/Labelling Problem 16 16
Migration 12 12
Physical Resistance/Sticking 12 12
Material Integrity Problem 12 12
Peeled/Delaminated 10 10
Device Dislodged or Dislocated 10 10
Patient-Device Incompatibility 10 10
Device-Device Incompatibility 9 9
Deformation Due to Compressive Stress 9 9
Difficult to Insert 9 9
Material Split, Cut or Torn 7 7
Difficult or Delayed Activation 7 7
Migration or Expulsion of Device 6 6
Device Contamination with Chemical or Other Material 6 6
Use of Device Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Loss of or Failure to Bond 5 5
Crack 5 5
Unsealed Device Packaging 4 4
Appropriate Term/Code Not Available 4 4
Material Frayed 4 4
Component Missing 3 3
Obstruction of Flow 3 3
Difficult to Open or Remove Packaging Material 3 3
Off-Label Use 3 3
Device Difficult to Setup or Prepare 2 2
Contamination 2 2
Therapeutic or Diagnostic Output Failure 2 2
Loose or Intermittent Connection 2 2
Defective Component 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 642 642
Thrombosis/Thrombus 152 152
Stroke/CVA 103 103
Ischemia Stroke 94 94
No Consequences Or Impact To Patient 93 93
Obstruction/Occlusion 52 52
Stenosis 40 40
Transient Ischemic Attack 35 35
Restenosis 30 30
Myocardial Infarction 29 29
Vascular Dissection 27 27
Muscle Weakness 24 24
Low Blood Pressure/ Hypotension 22 22
Insufficient Information 19 19
Dysphasia 15 15
Bradycardia 14 14
Brain Injury 14 14
Intracranial Hemorrhage 13 13
Hematoma 13 13
Foreign Body In Patient 12 12
Embolism/Embolus 11 11
Unspecified Tissue Injury 11 11
Hemorrhage/Bleeding 11 11
Perforation of Vessels 7 7
No Patient Involvement 7 7
No Known Impact Or Consequence To Patient 7 7
Dizziness 6 6
Thrombosis 6 6
Patient Problem/Medical Problem 6 6
High Blood Pressure/ Hypertension 6 6
Convulsion/Seizure 5 5
Speech Disorder 5 5
Paresis 5 5
Pain 5 5
Occlusion 4 4
Vasoconstriction 4 4
Swelling/ Edema 4 4
Extravasation 4 4
Nervous System Injury 4 4
Aneurysm 3 3
Headache 3 3
Visual Impairment 3 3
Loss of consciousness 3 3
Thrombus 3 3
Unspecified Nervous System Problem 3 3
Confusion/ Disorientation 3 3
Unspecified Infection 3 3
Cardiac Arrest 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hemorrhagic Stroke 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Cordis Corporation I Mar-15-2021
2 Silk Road Medical Inc II Feb-23-2021
-
-