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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)
2018
2019
2020
2021
2022
2023
0
4
10
11
5
6
MDR Year
MDR Reports
MDR Events
2019
24
24
2020
117
117
2021
425
425
2022
115
115
2023
178
178
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation Failure
386
386
Adverse Event Without Identified Device or Use Problem
107
107
Migration
79
79
Material Deformation
69
69
Activation, Positioning or Separation Problem
53
53
Fracture
51
51
Improper or Incorrect Procedure or Method
39
39
Migration or Expulsion of Device
32
32
Positioning Failure
30
30
Off-Label Use
29
29
Entrapment of Device
28
28
Difficult to Remove
23
23
Misfire
23
23
Difficult or Delayed Positioning
19
19
Malposition of Device
18
18
Break
17
17
Deformation Due to Compressive Stress
16
16
Use of Device Problem
14
14
Detachment of Device or Device Component
14
14
Obstruction of Flow
11
11
Material Twisted/Bent
9
9
No Apparent Adverse Event
8
8
Premature Activation
8
8
Device Damaged by Another Device
7
7
Positioning Problem
7
7
Physical Resistance/Sticking
7
7
Device Markings/Labelling Problem
6
6
Device-Device Incompatibility
6
6
Difficult to Advance
5
5
Structural Problem
5
5
Loss of or Failure to Bond
5
5
Material Fragmentation
4
4
Mechanical Problem
4
4
Appropriate Term/Code Not Available
4
4
Material Integrity Problem
3
3
Activation Problem
3
3
Nonstandard Device
3
3
Failure to Advance
3
3
Device Damaged Prior to Use
3
3
Stretched
2
2
Difficult or Delayed Activation
2
2
Defective Device
2
2
Retraction Problem
2
2
Material Too Rigid or Stiff
2
2
Material Separation
2
2
Inaccurate Information
2
2
Human-Device Interface Problem
2
2
Compatibility Problem
1
1
Material Protrusion/Extrusion
1
1
Mechanical Jam
1
1
Insufficient Information
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
Tear, Rip or Hole in Device Packaging
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Dislodged or Dislocated
1
1
Device Contamination with Chemical or Other Material
1
1
Biocompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
592
592
Thrombosis/Thrombus
65
65
Obstruction/Occlusion
41
41
Insufficient Information
37
37
No Consequences Or Impact To Patient
27
27
Pain
24
24
Restenosis
19
19
Stenosis
13
13
Chest Pain
11
11
Swelling/ Edema
11
11
Device Embedded In Tissue or Plaque
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
9
9
Dyspnea
9
9
No Known Impact Or Consequence To Patient
8
8
Unspecified Tissue Injury
7
7
Foreign Body In Patient
5
5
No Code Available
5
5
Hypersensitivity/Allergic reaction
5
5
Failure of Implant
5
5
Injury
5
5
Perforation
5
5
Swelling
5
5
Thrombosis
4
4
Reocclusion
4
4
Stroke/CVA
4
4
Hemorrhage/Bleeding
4
4
Unintended Radiation Exposure
4
4
Unspecified Heart Problem
4
4
Cellulitis
3
3
Pulmonary Embolism
3
3
Stacking Breaths
3
3
Arrhythmia
3
3
Tachycardia
3
3
Paralysis
2
2
Nerve Damage
2
2
Occlusion
2
2
Ulcer
2
2
Atrial Fibrillation
2
2
Respiratory Insufficiency
2
2
Pancreatitis
2
2
Pericardial Effusion
2
2
Embolism/Embolus
2
2
Foreign Body Embolism
2
2
No Patient Involvement
2
2
Vascular Dissection
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
Urticaria
1
1
Rupture
1
1
Cardiac Tamponade
1
1
Hematuria
1
1
Perforation of Vessels
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
May-05-2021
4
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Jan-06-2022
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