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TPLC
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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)
2020
2021
2022
2023
2024
2025
6
5
6
9
8
0
MDR Year
MDR Reports
MDR Events
2020
183
183
2021
235
235
2022
287
287
2023
303
303
2024
448
448
2025
30
30
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Dislodged or Dislocated
593
593
Adverse Event Without Identified Device or Use Problem
125
125
Complete Blockage
103
103
Device-Device Incompatibility
95
95
Material Deformation
80
80
Obstruction of Flow
76
76
Detachment of Device or Device Component
73
73
Patient-Device Incompatibility
65
65
Retraction Problem
48
48
Failure to Advance
44
44
Premature Separation
44
44
Migration
44
44
Device Stenosis
43
43
Collapse
40
40
Insufficient Information
35
35
Difficult to Advance
25
25
Partial Blockage
24
24
Break
23
23
Activation, Positioning or Separation Problem
23
23
Material Rupture
22
22
Difficult to Open or Remove Packaging Material
20
20
Appropriate Term/Code Not Available
20
20
Fracture
17
17
Migration or Expulsion of Device
17
17
Difficult to Remove
17
17
Malposition of Device
15
15
Separation Failure
15
15
Deformation Due to Compressive Stress
15
15
Positioning Failure
14
14
Difficult to Insert
13
13
Patient Device Interaction Problem
13
13
Deflation Problem
13
13
Inflation Problem
12
12
Separation Problem
12
12
Inaccurate Information
12
12
Expiration Date Error
12
12
Material Split, Cut or Torn
11
11
Leak/Splash
11
11
Fluid/Blood Leak
11
11
Material Separation
10
10
Positioning Problem
10
10
Activation Failure
10
10
Material Integrity Problem
9
9
Packaging Problem
8
8
Improper or Incorrect Procedure or Method
8
8
Inadequacy of Device Shape and/or Size
7
7
Material Invagination
6
6
No Apparent Adverse Event
6
6
Physical Resistance/Sticking
5
5
Premature Activation
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
763
763
Obstruction/Occlusion
153
153
Thrombosis/Thrombus
95
95
Aneurysm
58
58
Insufficient Information
55
55
Stenosis
51
51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
51
51
No Consequences Or Impact To Patient
43
43
Occlusion
36
36
No Code Available
24
24
Foreign Body In Patient
22
22
Renal Impairment
21
21
No Known Impact Or Consequence To Patient
21
21
Renal Failure
20
20
Vascular Dissection
20
20
Perforation of Vessels
18
18
Hemorrhage/Bleeding
17
17
Pain
15
15
No Patient Involvement
13
13
Low Blood Pressure/ Hypotension
10
10
Unspecified Infection
10
10
Ischemia
8
8
Unspecified Vascular Problem
8
8
Death
7
7
Failure of Implant
5
5
Pseudoaneurysm
5
5
Injury
4
4
Device Embedded In Tissue or Plaque
4
4
Paraplegia
3
3
Rupture
3
3
Thrombus
3
3
Perforation
3
3
Foreign Body Embolism
3
3
Ruptured Aneurysm
3
3
Blood Loss
3
3
Restenosis
3
3
Hematoma
3
3
Calcium Deposits/Calcification
3
3
Abdominal Pain
3
3
No Information
2
2
Nervous System Injury
2
2
Multiple Organ Failure
2
2
Solid Tumour
2
2
Thrombosis
2
2
Exsanguination
2
2
Stroke/CVA
2
2
Claudication
2
2
Not Applicable
1
1
Thrombocytopenia
1
1
Arteriosclerosis/ Atherosclerosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
II
Oct-07-2024
2
Atrium Medical Corporation
II
Nov-11-2023
3
W L Gore & Associates, Inc.
II
Aug-30-2024
4
W L Gore & Associates, Inc.
II
Oct-08-2021
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