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TPLC
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show TPLC since
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2024
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Device
stent, renal
Definition
Stent, Renal -- a metal scaffold placed via a delivery catheter into the renal artery to maintain the lumen
Product Code
NIN
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
4
10
13
25
11
14
8
11
12
6
4
4
4
4
6
0
MDR Year
MDR Reports
MDR Events
2014
28
28
2015
70
70
2016
34
34
2017
61
61
2018
123
123
2019
62
62
2020
55
55
2021
47
47
2022
39
39
2023
47
47
2024
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Dislodged or Dislocated
169
169
Failure to Advance
84
84
Difficult to Remove
83
83
Adverse Event Without Identified Device or Use Problem
80
80
Improper or Incorrect Procedure or Method
50
50
Material Deformation
39
39
Difficult to Advance
33
33
Leak/Splash
29
29
Off-Label Use
24
24
Material Rupture
21
21
Break
18
18
Activation Failure
18
18
Migration or Expulsion of Device
17
17
Premature Separation
15
15
Material Separation
14
14
Difficult To Position
14
14
Inflation Problem
13
13
Detachment Of Device Component
13
13
Insufficient Information
11
11
Activation, Positioning or Separation Problem
10
10
Unstable
9
9
Migration
9
9
Positioning Failure
9
9
Difficult or Delayed Positioning
8
8
Unintended System Motion
8
8
Device Operates Differently Than Expected
7
7
Detachment of Device or Device Component
6
6
Difficult or Delayed Activation
6
6
Malposition of Device
6
6
Premature Activation
5
5
Fracture
5
5
Difficult to Insert
4
4
Contamination
4
4
Deflation Problem
4
4
Deformation Due to Compressive Stress
4
4
Physical Resistance
4
4
Material Twisted/Bent
4
4
Positioning Problem
3
3
Appropriate Term/Code Not Available
3
3
Physical Resistance/Sticking
3
3
Patient-Device Incompatibility
3
3
Device Damaged by Another Device
3
3
Burst Container or Vessel
3
3
Occlusion Within Device
3
3
Inadequacy of Device Shape and/or Size
3
3
Device Slipped
3
3
Tear, Rip or Hole in Device Packaging
2
2
Obstruction of Flow
2
2
Retraction Problem
2
2
Kinked
2
2
Failure to Fold
2
2
Fluid/Blood Leak
2
2
Infusion or Flow Problem
2
2
Defective Device
2
2
Material Split, Cut or Torn
2
2
Device Handling Problem
1
1
Torn Material
1
1
Mechanical Jam
1
1
Output Problem
1
1
Packaging Problem
1
1
Physical Property Issue
1
1
Expiration Date Error
1
1
Separation Failure
1
1
Blocked Connection
1
1
Delivery System Failure
1
1
Device-Device Incompatibility
1
1
Device Markings/Labelling Problem
1
1
Difficult to Fold, Unfold or Collapse
1
1
Complete Blockage
1
1
Material Fragmentation
1
1
Loose or Intermittent Connection
1
1
Material Too Rigid or Stiff
1
1
Material Puncture/Hole
1
1
Product Quality Problem
1
1
Peeled/Delaminated
1
1
Component Missing
1
1
Out-Of-Box Failure
1
1
Sticking
1
1
Device Inoperable
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
192
192
No Clinical Signs, Symptoms or Conditions
105
105
No Known Impact Or Consequence To Patient
32
32
No Code Available
26
26
Hemorrhage/Bleeding
26
26
Foreign Body In Patient
24
24
Occlusion
24
24
No Patient Involvement
23
23
No Information
21
21
Thrombosis
21
21
Ischemia
19
19
Death
19
19
Stenosis
18
18
Vascular Dissection
15
15
Hematoma
12
12
Device Embedded In Tissue or Plaque
11
11
Pain
10
10
Renal Failure
10
10
Rupture
8
8
Perforation
8
8
Vessel Or Plaque, Device Embedded In
7
7
Obstruction/Occlusion
7
7
Pseudoaneurysm
7
7
Insufficient Information
7
7
Blood Loss
6
6
Embolism
6
6
Intimal Dissection
5
5
Aneurysm
4
4
Collapse
4
4
Embolism/Embolus
4
4
Thrombosis/Thrombus
3
3
Arrhythmia
3
3
Calcium Deposits/Calcification
3
3
Infarction, Cerebral
3
3
High Blood Pressure/ Hypertension
3
3
Low Blood Pressure/ Hypotension
2
2
Failure of Implant
2
2
Unspecified Infection
2
2
Pneumonia
2
2
Hypersensitivity/Allergic reaction
2
2
Myocardial Infarction
2
2
Nausea
2
2
Stroke/CVA
2
2
Bacterial Infection
2
2
Sepsis
2
2
Impaired Healing
2
2
Respiratory Failure
2
2
Multiple Organ Failure
2
2
Test Result
1
1
Organ Dehiscence
1
1
Claudication
1
1
Hematuria
1
1
Swelling
1
1
Paralysis
1
1
Thrombus
1
1
Vasoconstriction
1
1
Vomiting
1
1
Weakness
1
1
Dizziness
1
1
Respiratory Tract Infection
1
1
Spinal Cord Injury
1
1
Paraplegia
1
1
Cardiogenic Shock
1
1
Discomfort
1
1
Injury
1
1
Bradycardia
1
1
Angina
1
1
Pulmonary Embolism
1
1
Adult Respiratory Distress Syndrome
1
1
Wound Dehiscence
1
1
Cardiac Arrest
1
1
Embolus
1
1
Extravasation
1
1
Fever
1
1
Fistula
1
1
Pneumothorax
1
1
Rash
1
1
Renal Disease, End Stage
1
1
Inflammation
1
1
Chest Pain
1
1
Hemorrhage, Cerebral
1
1
Intracranial Hemorrhage
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Inc.
II
May-08-2020
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