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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)
2019
2020
2021
2022
2023
2024
4
10
11
5
7
3
MDR Year
MDR Reports
MDR Events
2019
24
24
2020
117
117
2021
425
425
2022
115
115
2023
208
208
2024
21
21
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation Failure
403
403
Adverse Event Without Identified Device or Use Problem
118
118
Migration
80
80
Material Deformation
77
77
Activation, Positioning or Separation Problem
58
58
Fracture
56
56
Improper or Incorrect Procedure or Method
42
42
Migration or Expulsion of Device
32
32
Off-Label Use
31
31
Entrapment of Device
30
30
Positioning Failure
30
30
Difficult to Remove
25
25
Use of Device Problem
24
24
Misfire
23
23
Break
20
20
Difficult or Delayed Positioning
20
20
Malposition of Device
19
19
Deformation Due to Compressive Stress
18
18
Detachment of Device or Device Component
16
16
Premature Activation
11
11
Obstruction of Flow
11
11
Material Twisted/Bent
10
10
Positioning Problem
8
8
No Apparent Adverse Event
8
8
Device Damaged by Another Device
7
7
Physical Resistance/Sticking
7
7
Device-Device Incompatibility
6
6
Device Markings/Labelling Problem
6
6
Structural Problem
5
5
Loss of or Failure to Bond
5
5
Difficult to Advance
5
5
Activation Problem
4
4
Appropriate Term/Code Not Available
4
4
Material Fragmentation
4
4
Mechanical Problem
4
4
Failure to Advance
3
3
Device Damaged Prior to Use
3
3
Defective Device
3
3
Nonstandard Device
3
3
Material Integrity Problem
3
3
Device Dislodged or Dislocated
2
2
Human-Device Interface Problem
2
2
Inaccurate Information
2
2
Delivered as Unsterile Product
2
2
Retraction Problem
2
2
Material Too Rigid or Stiff
2
2
Material Separation
2
2
Difficult or Delayed Activation
2
2
Stretched
2
2
Tear, Rip or Hole in Device Packaging
1
1
Biocompatibility
1
1
Inadequacy of Device Shape and/or Size
1
1
Poor Quality Image
1
1
Labelling, Instructions for Use or Training Problem
1
1
No Display/Image
1
1
Compatibility Problem
1
1
Fail-Safe Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Difficult to Open or Remove Packaging Material
1
1
Material Protrusion/Extrusion
1
1
Mechanical Jam
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
630
630
Thrombosis/Thrombus
73
73
Obstruction/Occlusion
41
41
Insufficient Information
39
39
No Consequences Or Impact To Patient
27
27
Pain
26
26
Restenosis
21
21
Stenosis
14
14
Chest Pain
12
12
Dyspnea
11
11
Swelling/ Edema
11
11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
10
10
Device Embedded In Tissue or Plaque
9
9
No Known Impact Or Consequence To Patient
8
8
Unspecified Tissue Injury
7
7
Perforation
6
6
Swelling
5
5
Hypersensitivity/Allergic reaction
5
5
Failure of Implant
5
5
No Code Available
5
5
Injury
5
5
Foreign Body In Patient
5
5
Unintended Radiation Exposure
4
4
Unspecified Heart Problem
4
4
Stroke/CVA
4
4
Hemorrhage/Bleeding
4
4
Thrombosis
4
4
Reocclusion
4
4
Tachycardia
3
3
Cellulitis
3
3
Pulmonary Embolism
3
3
Stacking Breaths
3
3
Arrhythmia
3
3
Atrial Fibrillation
2
2
Ulcer
2
2
Local Reaction
2
2
Paralysis
2
2
Nerve Damage
2
2
Occlusion
2
2
Respiratory Insufficiency
2
2
Pancreatitis
2
2
No Patient Involvement
2
2
Pericardial Effusion
2
2
Embolism/Embolus
2
2
Foreign Body Embolism
2
2
Hematuria
1
1
Vascular Dissection
1
1
Rash
1
1
Urticaria
1
1
Rupture
1
1
Cardiac Tamponade
1
1
Perforation of Vessels
1
1
Abdominal Pain
1
1
Edema
1
1
Extravasation
1
1
Hematoma
1
1
Intimal Dissection
1
1
Inflammation
1
1
Nausea
1
1
High Blood Pressure/ Hypertension
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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