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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
2
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
100
100
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Dislodged or Dislocated
597
597
Device-Device Incompatibility
123
123
Adverse Event Without Identified Device or Use Problem
115
115
Complete Blockage
73
73
Obstruction of Flow
71
71
Patient-Device Incompatibility
62
62
Detachment of Device or Device Component
56
56
Failure to Advance
47
47
Material Deformation
40
40
Collapse
34
34
Migration
34
34
Premature Separation
32
32
Insufficient Information
30
30
Retraction Problem
26
26
Activation, Positioning or Separation Problem
26
26
Partial Blockage
22
22
Device Stenosis
20
20
Break
18
18
Material Rupture
18
18
Migration or Expulsion of Device
18
18
Difficult to Advance
18
18
Material Split, Cut or Torn
16
16
Deformation Due to Compressive Stress
15
15
Occlusion Within Device
14
14
Difficult to Insert
14
14
Patient Device Interaction Problem
14
14
Appropriate Term/Code Not Available
13
13
Inflation Problem
13
13
Difficult to Remove
12
12
Separation Problem
12
12
Physical Resistance
11
11
Leak/Splash
11
11
Deflation Problem
11
11
Positioning Failure
10
10
Positioning Problem
10
10
Difficult to Open or Remove Packaging Material
9
9
Malposition of Device
9
9
Fluid/Blood Leak
9
9
Fracture
9
9
Material Separation
8
8
Separation Failure
8
8
Packaging Problem
8
8
Activation Failure
7
7
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
Unintended Movement
5
5
No Apparent Adverse Event
5
5
Physical Resistance/Sticking
5
5
Device Markings/Labelling Problem
4
4
Sticking
4
4
Component Missing
4
4
Material Puncture/Hole
4
4
Burst Container or Vessel
3
3
Disconnection
3
3
Entrapment of Device
3
3
Difficult or Delayed Positioning
3
3
Stretched
3
3
Activation Problem
3
3
Failure to Deflate
3
3
Device Handling Problem
2
2
Device Damaged Prior to Use
2
2
Nonstandard Device
2
2
Device Slipped
2
2
Loose or Intermittent Connection
2
2
Mechanical Problem
1
1
Optical Decentration
1
1
Perivalvular Leak
1
1
Difficult To Position
1
1
Premature Activation
1
1
Device Difficult to Setup or Prepare
1
1
Off-Label Use
1
1
Material Fragmentation
1
1
Bent
1
1
Backflow
1
1
Component Falling
1
1
Crack
1
1
Defective Component
1
1
Microbial Contamination of Device
1
1
Device Contamination with Body Fluid
1
1
Failure to Deliver
1
1
Fitting Problem
1
1
Material Perforation
1
1
Difficult or Delayed Activation
1
1
Structural Problem
1
1
Folded
1
1
Delivery System Failure
1
1
Device Operates Differently Than Expected
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
Incomplete or Inadequate Connection
1
1
Incomplete or Inadequate Priming
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
508
508
No Consequences Or Impact To Patient
181
181
Obstruction/Occlusion
118
118
Thrombosis/Thrombus
78
78
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
41
41
Occlusion
40
40
Insufficient Information
34
34
No Code Available
28
28
Renal Failure
19
19
Foreign Body In Patient
18
18
Vascular Dissection
17
17
Death
17
17
Pain
14
14
Hemorrhage/Bleeding
13
13
Perforation of Vessels
12
12
Injury
12
12
Renal Impairment
10
10
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
Ruptured Aneurysm
3
3
Rupture
3
3
Paraplegia
3
3
Perforation
3
3
Rash
2
2
Low Blood Pressure/ Hypotension
2
2
Stroke/CVA
2
2
Embolism
2
2
Exsanguination
2
2
Hematoma
2
2
Ambulation Difficulties
2
2
Thrombosis
2
2
Nervous System Injury
2
2
Solid Tumour
2
2
Foreign Body Embolism
2
2
Restenosis
2
2
Swelling/ Edema
1
1
Implant Pain
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Not Applicable
1
1
Arteriosclerosis/ Atherosclerosis
1
1
Unspecified Hepatic or Biliary Problem
1
1
Thrombocytopenia
1
1
Transient Ischemic Attack
1
1
Laceration(s)
1
1
Shock
1
1
Complaint, Ill-Defined
1
1
Cardiogenic Shock
1
1
Jaundice
1
1
Adhesion(s)
1
1
Extravasation
1
1
Embolus
1
1
Hypovolemic Shock
1
1
Hypersensitivity/Allergic reaction
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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