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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
1
MDR Year
MDR Reports
MDR Events
2020
117
117
2021
425
425
2022
115
115
2023
208
208
2024
128
128
2025
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation Failure
418
418
Adverse Event Without Identified Device or Use Problem
145
145
Material Deformation
87
87
Migration
86
86
Fracture
64
64
Activation, Positioning or Separation Problem
61
61
Improper or Incorrect Procedure or Method
47
47
Migration or Expulsion of Device
37
37
Off-Label Use
36
36
Positioning Failure
33
33
Entrapment of Device
27
27
Use of Device Problem
27
27
Malposition of Device
26
26
Difficult to Remove
24
24
Misfire
24
24
Break
19
19
Difficult or Delayed Positioning
19
19
Deformation Due to Compressive Stress
18
18
Detachment of Device or Device Component
17
17
Premature Activation
13
13
Material Twisted/Bent
11
11
Difficult to Advance
10
10
Device Damaged by Another Device
9
9
Obstruction of Flow
8
8
Physical Resistance/Sticking
8
8
Positioning Problem
8
8
No Apparent Adverse Event
8
8
Device Markings/Labelling Problem
7
7
Device-Device Incompatibility
6
6
Structural Problem
6
6
Loss of or Failure to Bond
5
5
Material Fragmentation
4
4
Device Dislodged or Dislocated
4
4
Activation Problem
4
4
Appropriate Term/Code Not Available
4
4
Mechanical Problem
4
4
Failure to Advance
3
3
Device Damaged Prior to Use
3
3
Nonstandard Device
3
3
Defective Device
3
3
Inaccurate Information
2
2
Difficult or Delayed Activation
2
2
Material Separation
2
2
Stretched
2
2
Material Too Rigid or Stiff
2
2
Biocompatibility
2
2
Delivered as Unsterile Product
2
2
Poor Quality Image
1
1
Shipping Damage or Problem
1
1
Mechanical Jam
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
698
698
Thrombosis/Thrombus
77
77
Insufficient Information
52
52
Obstruction/Occlusion
51
51
Pain
32
32
Restenosis
25
25
No Consequences Or Impact To Patient
16
16
Chest Pain
15
15
Stenosis
14
14
Swelling/ Edema
14
14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
13
13
Dyspnea
12
12
Device Embedded In Tissue or Plaque
9
9
Unspecified Tissue Injury
7
7
Pulmonary Embolism
6
6
Foreign Body In Patient
6
6
Hypersensitivity/Allergic reaction
6
6
Perforation
6
6
No Code Available
5
5
Hemorrhage/Bleeding
5
5
Failure of Implant
5
5
Unspecified Heart Problem
4
4
Injury
4
4
Unintended Radiation Exposure
4
4
Swelling
4
4
Stroke/CVA
4
4
Ulcer
3
3
Tachycardia
3
3
Cellulitis
3
3
No Known Impact Or Consequence To Patient
3
3
Thrombosis
3
3
Arrhythmia
3
3
Stacking Breaths
3
3
Embolism/Embolus
3
3
Paralysis
2
2
Rash
2
2
Nerve Damage
2
2
Local Reaction
2
2
Pancreatitis
2
2
Respiratory Insufficiency
2
2
Foreign Body Embolism
2
2
Pericardial Effusion
2
2
Fever
2
2
Atrial Fibrillation
2
2
Vascular Dissection
1
1
Valvular Insufficiency/ Regurgitation
1
1
No Patient Involvement
1
1
Numbness
1
1
Urticaria
1
1
Itching Sensation
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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