Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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, iliac vein
Definition A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen
Product CodeQAN
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
11 5 7 9 5 1

MDR Year MDR Reports MDR Events
2021 425 426
2022 115 115
2023 208 210
2024 128 128
2025 177 177
2026 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 347 347
Adverse Event Without Identified Device or Use Problem 189 189
Material Deformation 103 103
Migration 90 90
Activation, Positioning or Separation Problem 72 72
Fracture 70 72
Improper or Incorrect Procedure or Method 53 53
Migration or Expulsion of Device 42 42
Off-Label Use 39 40
Positioning Failure 38 38
Obstruction of Flow 37 38
Malposition of Device 29 29
Detachment of Device or Device Component 28 28
Use of Device Problem 27 27
Difficult to Remove 23 23
Break 22 22
Deformation Due to Compressive Stress 21 21
Misfire 20 20
Premature Activation 18 18
Entrapment of Device 17 17
Difficult or Delayed Positioning 17 17
Difficult to Advance 16 16
Material Twisted/Bent 10 10
Device Damaged by Another Device 9 9
Physical Resistance/Sticking 9 9
Device Markings/Labelling Problem 9 9
Positioning Problem 8 8
Loss of or Failure to Bond 8 8
No Apparent Adverse Event 7 7
Packaging Problem 7 7
Device-Device Incompatibility 6 6
Device Dislodged or Dislocated 6 6
Difficult or Delayed Activation 6 6
Structural Problem 6 6
Nonstandard Device 5 5
Failure to Advance 5 5
Material Fragmentation 4 4
Defective Device 4 4
Activation Problem 4 4
Biocompatibility 3 3
Mechanical Problem 3 3
Delivered as Unsterile Product 3 3
Device Damaged Prior to Use 3 3
Material Separation 2 2
Incomplete or Missing Packaging 2 2
Material Too Rigid or Stiff 2 2
Appropriate Term/Code Not Available 2 2
Stretched 2 2
Sharp Edges 1 1
Poor Quality Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 707 707
Thrombosis/Thrombus 105 106
Insufficient Information 68 69
Obstruction/Occlusion 64 64
Pain 44 44
Restenosis 39 39
Stenosis 22 22
Swelling/ Edema 18 18
Chest Pain 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Dyspnea 12 12
Foreign Body In Patient 9 9
Pulmonary Embolism 8 8
Hypersensitivity/Allergic reaction 8 8
Device Embedded In Tissue or Plaque 7 7
Hemorrhage/Bleeding 7 7
Unspecified Tissue Injury 7 7
Perforation 6 6
Hematoma 6 6
Failure of Implant 5 5
Ulcer 5 5
Unintended Radiation Exposure 4 4
Unspecified Heart Problem 4 4
Unspecified Infection 4 4
Stroke/CVA 4 4
Embolism/Embolus 3 3
Tachycardia 3 3
Perforation of Vessels 3 3
Pericardial Effusion 3 3
Local Reaction 3 3
Arrhythmia 3 3
Cellulitis 3 3
Stacking Breaths 3 3
Rash 3 3
Respiratory Insufficiency 2 2
Pseudoaneurysm 2 2
Foreign Body Embolism 2 2
Nerve Damage 2 2
Fever 2 2
Paralysis 2 2
Pancreatitis 2 2
Paresthesia 2 2
Anemia 2 2
Rupture 2 2
Atrial Fibrillation 2 2
No Code Available 2 2
Nausea 2 2
Purulent Discharge 1 1
Numbness 1 1
Erythema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Jun-17-2021
2 Boston Scientific Corporation I May-19-2021
3 Medtronic Inc II Jan-15-2026
4 Medtronic Inc. II Mar-19-2024
5 Medtronic Inc. II May-05-2021
6 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jan-06-2022
-
-