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TPLC
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show TPLC since
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2024
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Device
iliac covered stent, arterial
Definition
For the treatment of de novo or restenotic lesions found in iliac arteries
Product Code
PRL
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
0
0
0
0
0
0
0
0
7
14
9
6
5
6
9
3
MDR Year
MDR Reports
MDR Events
2017
91
91
2018
102
102
2019
99
99
2020
183
183
2021
235
235
2022
287
287
2023
303
303
2024
184
184
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Dislodged or Dislocated
640
640
Device-Device Incompatibility
131
131
Adverse Event Without Identified Device or Use Problem
122
122
Complete Blockage
81
81
Obstruction of Flow
75
75
Patient-Device Incompatibility
63
63
Detachment of Device or Device Component
59
59
Failure to Advance
50
50
Material Deformation
41
41
Migration
37
37
Collapse
34
34
Premature Separation
33
33
Insufficient Information
30
30
Retraction Problem
30
30
Activation, Positioning or Separation Problem
27
27
Device Stenosis
24
24
Migration or Expulsion of Device
22
22
Partial Blockage
22
22
Material Rupture
21
21
Difficult to Advance
20
20
Break
19
19
Material Split, Cut or Torn
16
16
Appropriate Term/Code Not Available
15
15
Difficult to Insert
15
15
Deformation Due to Compressive Stress
15
15
Occlusion Within Device
14
14
Patient Device Interaction Problem
14
14
Inflation Problem
13
13
Difficult to Remove
13
13
Separation Problem
12
12
Physical Resistance
11
11
Malposition of Device
11
11
Positioning Problem
11
11
Fracture
11
11
Deflation Problem
11
11
Leak/Splash
11
11
Positioning Failure
10
10
Fluid/Blood Leak
10
10
Difficult to Open or Remove Packaging Material
10
10
Separation Failure
9
9
Packaging Problem
8
8
Material Separation
8
8
Activation Failure
8
8
Improper or Incorrect Procedure or Method
7
7
Inadequacy of Device Shape and/or Size
6
6
Material Invagination
6
6
Detachment Of Device Component
6
6
No Apparent Adverse Event
6
6
Unintended Movement
5
5
Physical Resistance/Sticking
5
5
Material Puncture/Hole
4
4
Sticking
4
4
Component Missing
4
4
Device Markings/Labelling Problem
4
4
Stretched
3
3
Burst Container or Vessel
3
3
Disconnection
3
3
Entrapment of Device
3
3
Difficult or Delayed Positioning
3
3
Premature Activation
3
3
Activation Problem
3
3
Failure to Deflate
3
3
Device Handling Problem
2
2
Device Slipped
2
2
Nonstandard Device
2
2
Loose or Intermittent Connection
2
2
Device Damaged Prior to Use
2
2
Defective Component
1
1
Microbial Contamination of Device
1
1
Fitting Problem
1
1
Material Perforation
1
1
Device Contamination with Body Fluid
1
1
Failure to Deliver
1
1
Structural Problem
1
1
Difficult or Delayed Activation
1
1
Folded
1
1
Device Operates Differently Than Expected
1
1
Delivery System Failure
1
1
Human-Device Interface Problem
1
1
Compatibility Problem
1
1
Torn Material
1
1
Material Twisted/Bent
1
1
No Flow
1
1
Output Problem
1
1
Mechanical Problem
1
1
Optical Decentration
1
1
Device Difficult to Setup or Prepare
1
1
Off-Label Use
1
1
Perivalvular Leak
1
1
Difficult To Position
1
1
Material Fragmentation
1
1
Bent
1
1
Backflow
1
1
Component Falling
1
1
Crack
1
1
Incomplete or Inadequate Connection
1
1
Incomplete or Inadequate Priming
1
1
Unintended Deflation
1
1
Difficult or Delayed Separation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
563
563
No Consequences Or Impact To Patient
181
181
Obstruction/Occlusion
126
126
Thrombosis/Thrombus
79
79
No Known Impact Or Consequence To Patient
73
73
Stenosis
64
64
Aneurysm
60
60
No Patient Involvement
56
56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
42
42
Occlusion
40
40
Insufficient Information
35
35
No Code Available
28
28
Foreign Body In Patient
21
21
Renal Failure
21
21
Vascular Dissection
18
18
Death
17
17
Pain
15
15
Perforation of Vessels
13
13
Hemorrhage/Bleeding
13
13
Injury
12
12
Renal Impairment
11
11
Unspecified Infection
10
10
Ischemia
9
9
No Information
9
9
Unspecified Vascular Problem
8
8
Failure of Implant
7
7
Calcium Deposits/Calcification
6
6
Claudication
6
6
Thrombus
5
5
Device Embedded In Tissue or Plaque
4
4
Blood Loss
3
3
Pseudoaneurysm
3
3
Paraplegia
3
3
Ruptured Aneurysm
3
3
Perforation
3
3
Rupture
3
3
Abdominal Pain
3
3
Stroke/CVA
2
2
Embolism
2
2
Exsanguination
2
2
Hematoma
2
2
Low Blood Pressure/ Hypotension
2
2
Thrombosis
2
2
Rash
2
2
Foreign Body Embolism
2
2
Nervous System Injury
2
2
Ambulation Difficulties
2
2
Solid Tumour
2
2
Restenosis
2
2
Swelling/ Edema
1
1
Implant Pain
1
1
Unspecified Hepatic or Biliary Problem
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Not Applicable
1
1
Thrombocytopenia
1
1
Arteriosclerosis/ Atherosclerosis
1
1
Transient Ischemic Attack
1
1
Shock
1
1
Complaint, Ill-Defined
1
1
Cardiogenic Shock
1
1
Jaundice
1
1
Hypovolemic Shock
1
1
Hypersensitivity/Allergic reaction
1
1
Laceration(s)
1
1
Extravasation
1
1
Embolus
1
1
Adhesion(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
II
Nov-11-2023
2
Bard Peripheral Vascular Inc
II
Dec-19-2019
3
W L Gore & Associates, Inc.
II
Oct-08-2021
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