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TPLC
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Device
stent, iliac
Definition
Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen
Product Code
NIO
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
22
21
12
15
16
5
MDR Year
MDR Reports
MDR Events
2019
415
415
2020
409
409
2021
421
421
2022
352
352
2023
351
351
2024
76
76
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Dislodged or Dislocated
390
390
Adverse Event Without Identified Device or Use Problem
278
278
Difficult to Remove
187
187
Off-Label Use
161
161
Material Deformation
144
144
Failure to Advance
133
133
Difficult to Advance
123
123
Detachment of Device or Device Component
117
117
Premature Activation
94
94
Activation Failure
89
89
Improper or Incorrect Procedure or Method
86
86
Positioning Problem
85
85
Positioning Failure
79
79
Activation, Positioning or Separation Problem
77
77
Fracture
72
72
Break
70
70
Misfire
69
69
Migration
61
61
Difficult or Delayed Positioning
49
49
Entrapment of Device
41
41
Material Rupture
32
32
Device-Device Incompatibility
29
29
Insufficient Information
28
28
Obstruction of Flow
27
27
Malposition of Device
27
27
Patient-Device Incompatibility
26
26
Deformation Due to Compressive Stress
26
26
Migration or Expulsion of Device
26
26
Leak/Splash
22
22
Defective Device
22
22
Physical Resistance/Sticking
20
20
Material Split, Cut or Torn
19
19
Difficult or Delayed Activation
18
18
Material Separation
17
17
Stretched
17
17
Difficult to Insert
17
17
Partial Blockage
16
16
Use of Device Problem
16
16
Device Damaged by Another Device
16
16
Complete Blockage
15
15
Collapse
15
15
Device Damaged Prior to Use
12
12
Premature Separation
12
12
Material Integrity Problem
11
11
Burst Container or Vessel
11
11
Material Frayed
11
11
Material Twisted/Bent
10
10
Poor Visibility
10
10
Device Markings/Labelling Problem
9
9
Structural Problem
8
8
Inflation Problem
8
8
Defective Component
7
7
Patient Device Interaction Problem
6
6
Mechanical Jam
6
6
Device Contaminated During Manufacture or Shipping
6
6
Component Missing
5
5
Device Contamination with Chemical or Other Material
4
4
Unsealed Device Packaging
4
4
Deflation Problem
4
4
No Apparent Adverse Event
4
4
Activation Problem
4
4
Separation Problem
3
3
Difficult to Open or Remove Packaging Material
3
3
Appropriate Term/Code Not Available
3
3
Contamination
3
3
Self-Activation or Keying
3
3
Device Slipped
2
2
Tear, Rip or Hole in Device Packaging
2
2
Disconnection
2
2
Misassembled
2
2
Product Quality Problem
2
2
Loose or Intermittent Connection
2
2
Unintended Movement
2
2
Packaging Problem
2
2
Inaccurate Information
2
2
Failure to Deflate
1
1
Difficult or Delayed Separation
1
1
Noise, Audible
1
1
Difficult to Open or Close
1
1
Mechanical Problem
1
1
Labelling, Instructions for Use or Training Problem
1
1
Material Fragmentation
1
1
Decrease in Pressure
1
1
Unintended System Motion
1
1
Peeled/Delaminated
1
1
Accessory Incompatible
1
1
Fluid/Blood Leak
1
1
Difficult to Flush
1
1
Failure to Fold
1
1
Crack
1
1
Loss of or Failure to Bond
1
1
Unraveled Material
1
1
Unstable
1
1
Failure to Deliver
1
1
Inaccurate Delivery
1
1
Inadequacy of Device Shape and/or Size
1
1
Retraction Problem
1
1
Inadequate User Interface
1
1
Compatibility Problem
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
896
896
No Consequences Or Impact To Patient
335
335
No Known Impact Or Consequence To Patient
81
81
Occlusion
76
76
Foreign Body In Patient
63
63
Obstruction/Occlusion
62
62
Insufficient Information
59
59
No Information
56
56
Stenosis
53
53
Vascular Dissection
49
49
Blood Loss
44
44
Death
44
44
No Patient Involvement
43
43
Thrombosis/Thrombus
42
42
Ischemia
36
36
No Code Available
35
35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
33
33
Hematoma
32
32
Aneurysm
30
30
Restenosis
28
28
Thrombosis
26
26
Renal Failure
25
25
Hemorrhage/Bleeding
25
25
Unspecified Infection
22
22
Embolism/Embolus
19
19
Patient Problem/Medical Problem
19
19
Pseudoaneurysm
19
19
Device Embedded In Tissue or Plaque
18
18
Rupture
18
18
Stroke/CVA
17
17
Thrombus
16
16
Pain
16
16
Unspecified Tissue Injury
16
16
Perforation
15
15
Injury
14
14
Embolism
12
12
Myocardial Infarction
11
11
Reocclusion
11
11
Perforation of Vessels
10
10
High Blood Pressure/ Hypertension
7
7
Vessel Or Plaque, Device Embedded In
7
7
Thromboembolism
7
7
Claudication
6
6
Fever
6
6
Fistula
6
6
Hypersensitivity/Allergic reaction
6
6
Sepsis
5
5
Pneumonia
5
5
Respiratory Failure
5
5
Valvular Stenosis
5
5
Renal Impairment
4
4
Seroma
4
4
Inflammation
4
4
Low Blood Pressure/ Hypotension
4
4
Intimal Dissection
4
4
Arrhythmia
4
4
Dyspnea
4
4
Coagulation Disorder
3
3
Failure of Implant
3
3
Post Operative Wound Infection
3
3
Paraplegia
2
2
Discomfort
2
2
Reaction
2
2
Hematuria
2
2
Diminished Pulse Pressure
2
2
Hemorrhagic Stroke
2
2
Ruptured Aneurysm
2
2
Heart Failure/Congestive Heart Failure
2
2
Swelling/ Edema
2
2
Hypoxia
2
2
Encephalopathy
2
2
Stacking Breaths
2
2
Hypovolemia
2
2
Tissue Damage
2
2
Rash
2
2
Local Reaction
1
1
Seizures
1
1
Transient Ischemic Attack
1
1
Pulmonary Edema
1
1
Laceration(s)
1
1
Liver Damage/Dysfunction
1
1
Cardiac Tamponade
1
1
Hernia
1
1
Disability
1
1
Ulcer
1
1
Septic Shock
1
1
Heart Failure
1
1
Vomiting
1
1
Chills
1
1
Cramp(s)
1
1
Dizziness
1
1
Abscess
1
1
Anaphylactic Shock
1
1
Pulmonary Embolism
1
1
Atrial Fibrillation
1
1
Autoimmune Reaction
1
1
Bacterial Infection
1
1
Calcium Deposits/Calcification
1
1
Cardiac Arrest
1
1
Extravasation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health Inc.
II
Dec-20-2019
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