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TPLC
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show TPLC since
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Device
system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment
Definition
An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.
Product Code
PFV
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
5
7
4
5
7
17
12
14
13
17
13
12
12
8
9
4
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
54
54
2016
82
82
2017
195
195
2018
343
343
2019
376
376
2020
337
337
2021
281
281
2022
261
261
2023
229
229
2024
162
162
Device Problems
MDRs with this Device Problem
Events in those MDRs
Positioning Failure
789
789
Misfire
727
727
Fracture
503
503
Break
310
310
Adverse Event Without Identified Device or Use Problem
200
200
Detachment of Device or Device Component
149
149
Material Perforation
146
146
Obstruction of Flow
125
125
Activation Failure
121
121
Material Deformation
106
106
Malposition of Device
80
80
Difficult to Remove
77
77
Complete Blockage
76
76
Loss of or Failure to Bond
74
74
Difficult or Delayed Positioning
66
66
Retraction Problem
57
57
Patient-Device Incompatibility
48
48
Insufficient Information
48
48
Positioning Problem
43
43
Difficult to Advance
41
41
Activation, Positioning or Separation Problem
36
36
Migration or Expulsion of Device
32
32
Entrapment of Device
31
31
Failure to Advance
30
30
Material Separation
30
30
Premature Activation
27
27
Device-Device Incompatibility
24
24
Improper or Incorrect Procedure or Method
22
22
Difficult or Delayed Activation
22
22
Material Invagination
20
20
Separation Failure
20
20
Occlusion Within Device
18
18
Migration
16
16
Appropriate Term/Code Not Available
14
14
Partial Blockage
14
14
Packaging Problem
13
13
Activation Problem
13
13
Failure to Unfold or Unwrap
12
12
Device Dislodged or Dislocated
11
11
Off-Label Use
10
10
Device Damaged by Another Device
9
9
Material Twisted/Bent
9
9
Deformation Due to Compressive Stress
9
9
Material Split, Cut or Torn
9
9
Leak/Splash
7
7
Material Fragmentation
7
7
Device Markings/Labelling Problem
7
7
Mechanical Problem
6
6
No Apparent Adverse Event
6
6
Bent
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
773
773
No Clinical Signs, Symptoms or Conditions
738
738
Occlusion
137
137
No Known Impact Or Consequence To Patient
133
133
Restenosis
90
90
Stenosis
88
88
Aneurysm
46
46
No Code Available
45
45
Thrombosis
44
44
Pain
32
32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
31
31
Obstruction/Occlusion
31
31
Thrombosis/Thrombus
24
24
Unspecified Infection
23
23
Injury
22
22
Foreign Body In Patient
21
21
Death
20
20
Device Embedded In Tissue or Plaque
20
20
Hemorrhage/Bleeding
20
20
Perforation of Vessels
20
20
No Information
19
19
Pseudoaneurysm
19
19
Ischemia
16
16
Thrombus
15
15
No Patient Involvement
15
15
Embolism
12
12
Blood Loss
12
12
Perforation
10
10
Insufficient Information
9
9
Claudication
9
9
Vascular Dissection
8
8
Thromboembolism
8
8
Fistula
8
8
Vascular System (Circulation), Impaired
7
7
Hematoma
7
7
Sepsis
6
6
Unspecified Tissue Injury
5
5
Bacterial Infection
5
5
Swelling/ Edema
4
4
Extravasation
4
4
Not Applicable
4
4
Numbness
4
4
Encephalopathy
4
4
Renal Failure
3
3
Multiple Organ Failure
3
3
Rupture
3
3
Device Overstimulation of Tissue
3
3
Skin Erosion
3
3
Abscess
2
2
Great Vessel Perforation
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Bard Peripheral Vascular Inc
II
Feb-09-2023
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