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TPLC
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Device
stent, iliac vein
Definition
A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen
Product Code
QAN
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
10
11
5
7
9
2
MDR Year
MDR Reports
MDR Events
2020
117
117
2021
425
425
2022
115
115
2023
208
208
2024
128
128
2025
73
73
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation Failure
420
420
Adverse Event Without Identified Device or Use Problem
163
163
Material Deformation
95
95
Migration
89
89
Fracture
67
67
Activation, Positioning or Separation Problem
66
66
Improper or Incorrect Procedure or Method
51
51
Migration or Expulsion of Device
39
39
Off-Label Use
38
38
Positioning Failure
36
36
Malposition of Device
29
29
Entrapment of Device
27
27
Use of Device Problem
27
27
Difficult to Remove
26
26
Misfire
25
25
Break
22
22
Detachment of Device or Device Component
21
21
Difficult or Delayed Positioning
20
20
Deformation Due to Compressive Stress
18
18
Premature Activation
17
17
Obstruction of Flow
15
15
Difficult to Advance
11
11
Material Twisted/Bent
11
11
Device Damaged by Another Device
9
9
Physical Resistance/Sticking
8
8
Device Markings/Labelling Problem
8
8
Positioning Problem
8
8
No Apparent Adverse Event
8
8
Device-Device Incompatibility
7
7
Loss of or Failure to Bond
7
7
Structural Problem
6
6
Mechanical Problem
4
4
Activation Problem
4
4
Appropriate Term/Code Not Available
4
4
Device Dislodged or Dislocated
4
4
Material Fragmentation
4
4
Nonstandard Device
3
3
Failure to Advance
3
3
Packaging Problem
3
3
Delivered as Unsterile Product
3
3
Difficult or Delayed Activation
3
3
Defective Device
3
3
Device Damaged Prior to Use
3
3
Material Too Rigid or Stiff
2
2
Material Separation
2
2
Stretched
2
2
Inaccurate Information
2
2
Biocompatibility
2
2
Sharp Edges
1
1
Material Rupture
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
726
726
Thrombosis/Thrombus
85
85
Insufficient Information
59
59
Obstruction/Occlusion
56
56
Pain
38
38
Restenosis
26
26
Stenosis
17
17
No Consequences Or Impact To Patient
16
16
Swelling/ Edema
16
16
Chest Pain
15
15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
14
14
Dyspnea
12
12
Device Embedded In Tissue or Plaque
9
9
Unspecified Tissue Injury
7
7
Pulmonary Embolism
6
6
Hypersensitivity/Allergic reaction
6
6
Foreign Body In Patient
6
6
Perforation
6
6
Hemorrhage/Bleeding
5
5
No Code Available
5
5
Failure of Implant
5
5
Unintended Radiation Exposure
4
4
Unspecified Heart Problem
4
4
Swelling
4
4
Injury
4
4
Pericardial Effusion
4
4
Stroke/CVA
4
4
Arrhythmia
3
3
Ulcer
3
3
Tachycardia
3
3
No Known Impact Or Consequence To Patient
3
3
Cellulitis
3
3
Stacking Breaths
3
3
Embolism/Embolus
3
3
Thrombosis
3
3
Respiratory Insufficiency
2
2
Unspecified Infection
2
2
Pseudoaneurysm
2
2
Perforation of Vessels
2
2
Pancreatitis
2
2
Nausea
2
2
Foreign Body Embolism
2
2
Nerve Damage
2
2
Fever
2
2
Rash
2
2
Paralysis
2
2
Local Reaction
2
2
Rupture
2
2
Atrial Fibrillation
2
2
No Patient Involvement
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
Mar-19-2024
4
Medtronic Inc.
II
May-05-2021
5
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Jan-06-2022
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