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TPLC
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Device
stent, superficial femoral artery
Definition
Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen
Product Code
NIP
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
21
19
17
16
21
42
40
50
34
56
46
33
26
26
27
8
MDR Year
MDR Reports
MDR Events
2014
403
403
2015
600
600
2016
846
846
2017
789
789
2018
546
546
2019
716
716
2020
802
802
2021
837
837
2022
831
831
2023
879
879
2024
218
218
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1408
1408
Fracture
704
704
Activation Failure
688
688
Material Deformation
662
662
Activation, Positioning or Separation Problem
662
662
Difficult to Remove
633
633
Break
601
601
Positioning Failure
578
578
Material Separation
465
465
Premature Activation
394
394
Improper or Incorrect Procedure or Method
355
355
Detachment Of Device Component
341
341
Stretched
311
311
Difficult or Delayed Positioning
279
279
Difficult or Delayed Activation
247
247
Detachment of Device or Device Component
244
244
Occlusion Within Device
232
232
Failure to Advance
220
220
Mechanical Jam
207
207
Difficult to Advance
200
200
Entrapment of Device
185
185
Material Twisted/Bent
162
162
Physical Resistance/Sticking
139
139
Malposition of Device
131
131
Obstruction of Flow
124
124
Insufficient Information
109
109
Device Operates Differently Than Expected
102
102
Positioning Problem
98
98
Migration
97
97
Misfire
97
97
Bent
92
92
Device Dislodged or Dislocated
79
79
Patient-Device Incompatibility
76
76
Defective Device
75
75
Material Torqued
62
62
Migration or Expulsion of Device
62
62
Leak/Splash
61
61
Complete Blockage
60
60
Device Damaged by Another Device
53
53
Partial Blockage
41
41
Difficult To Position
40
40
Deformation Due to Compressive Stress
38
38
Sticking
37
37
Off-Label Use
32
32
Kinked
31
31
Physical Resistance
30
30
Difficult to Insert
29
29
Retraction Problem
28
28
Device-Device Incompatibility
27
27
Inaccurate Delivery
26
26
Activation Problem
26
26
Device Stenosis
25
25
Use of Device Problem
25
25
Separation Failure
24
24
Tear, Rip or Hole in Device Packaging
22
22
Device Markings/Labelling Problem
19
19
Device Expiration Issue
18
18
Torn Material
17
17
Material Split, Cut or Torn
16
16
Loss of or Failure to Bond
16
16
Mechanical Problem
16
16
Noise, Audible
15
15
No Apparent Adverse Event
15
15
Material Integrity Problem
14
14
Appropriate Term/Code Not Available
13
13
Failure to Eject
13
13
Component Missing
13
13
Product Quality Problem
13
13
Material Fragmentation
13
13
Contamination
12
12
Inadequacy of Device Shape and/or Size
11
11
Patient Device Interaction Problem
11
11
Self-Activation or Keying
10
10
Difficult or Delayed Separation
10
10
Separation Problem
9
9
Device Contamination with Chemical or Other Material
9
9
Packaging Problem
8
8
Delivered as Unsterile Product
8
8
Fluid/Blood Leak
8
8
Difficult to Flush
8
8
Microbial Contamination of Device
7
7
Premature Separation
7
7
Material Invagination
6
6
Device Difficult to Setup or Prepare
6
6
Defective Component
6
6
Device Damaged Prior to Use
5
5
Unintended System Motion
5
5
Material Rupture
5
5
Collapse
5
5
Device Contaminated During Manufacture or Shipping
5
5
Compatibility Problem
4
4
Material Protrusion/Extrusion
4
4
Unintended Movement
4
4
Device Handling Problem
4
4
Dent in Material
4
4
Expiration Date Error
4
4
Contamination /Decontamination Problem
4
4
Unsealed Device Packaging
4
4
Unintended Collision
4
4
Peeled/Delaminated
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
2367
2367
No Clinical Signs, Symptoms or Conditions
1714
1714
Stenosis
409
409
No Known Impact Or Consequence To Patient
356
356
Pain
347
347
Occlusion
329
330
Reocclusion
310
310
Restenosis
290
290
Obstruction/Occlusion
268
268
Claudication
250
250
Thrombosis
222
223
Foreign Body In Patient
220
220
Thrombosis/Thrombus
154
154
No Patient Involvement
148
148
Device Embedded In Tissue or Plaque
140
140
Insufficient Information
120
120
Death
106
106
Ischemia
102
102
Hemorrhage/Bleeding
97
97
No Code Available
82
82
Patient Problem/Medical Problem
73
73
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
72
72
Unspecified Infection
68
68
Vascular System (Circulation), Impaired
64
64
No Information
64
64
Thrombus
62
62
Vascular Dissection
61
61
Injury
60
60
Pseudoaneurysm
44
44
Aneurysm
38
38
Hematoma
36
36
Vessel Or Plaque, Device Embedded In
35
35
Embolism
34
34
Perforation
34
34
Perforation of Vessels
29
29
Unspecified Tissue Injury
26
26
Rupture
23
23
Stroke/CVA
22
22
Embolism/Embolus
20
20
Intimal Dissection
19
19
Diminished Pulse Pressure
19
19
Myocardial Infarction
17
18
Calcium Deposits/Calcification
15
15
Fistula
15
15
Tissue Damage
15
15
Renal Failure
15
15
Pneumonia
14
14
Low Blood Pressure/ Hypotension
14
15
Failure of Implant
14
14
Unspecified Vascular Problem
14
14
Bacterial Infection
13
13
Respiratory Distress
13
13
Numbness
13
13
Sepsis
12
12
Hypersensitivity/Allergic reaction
11
11
Discomfort
10
10
Swelling/ Edema
10
10
Paraplegia
9
9
Tissue Breakdown
9
9
Septic Shock
9
9
Swelling
9
9
Vasoconstriction
9
9
Fever
9
9
Cardiac Arrest
8
8
Test Result
8
8
Arteriosclerosis/ Atherosclerosis
8
8
Blood Loss
7
7
Impaired Healing
7
7
Skin Discoloration
7
7
Atrial Fibrillation
7
7
Abdominal Pain
7
7
Extravasation
6
6
Cramp(s) /Muscle Spasm(s)
6
6
Ruptured Aneurysm
5
5
Abscess
5
5
Laceration(s)
5
5
Necrosis
5
5
Cardiogenic Shock
5
5
Respiratory Failure
5
5
Weakness
4
4
Transient Ischemic Attack
4
4
Hemothorax
4
4
Inflammation
4
4
Angina
4
4
Arrhythmia
3
3
Anemia
3
3
Fall
3
3
Erythema
3
3
Chest Pain
3
3
Hypovolemic Shock
3
3
High Blood Pressure/ Hypertension
3
3
Headache
3
3
Neurological Deficit/Dysfunction
3
3
Nausea
3
3
Skin Erosion
3
3
Rash
3
3
Post Operative Wound Infection
3
3
Reaction
3
3
Ischemia Stroke
3
3
Localized Skin Lesion
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Bard Peripheral Vascular Inc
I
Oct-10-2013
2
Boston Scientific Corporation
II
Feb-22-2018
3
Boston Scientific Corporation
I
Jun-16-2011
4
Cardinal Health Inc.
II
Dec-20-2019
5
Cordis Corporation
II
Jun-06-2013
6
Ev3, Inc.
II
Jun-23-2016
7
Medtronic Inc.
II
Jan-02-2024
8
Medtronic Inc.
II
Aug-26-2022
9
Medtronic Inc.
II
Nov-29-2017
10
Terumo Medical Corp
II
Nov-29-2016
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