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TPLC
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Device
endovascular suturing system
Regulation Description
Endovascular Suturing System.
Definition
Provides fixation and sealing between and endovascular graft and the native artery.
Product Code
OTD
Regulation Number
870.3460
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
101
101
2021
59
59
2022
52
52
2023
52
52
2024
62
62
2025
19
19
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
169
169
Adverse Event Without Identified Device or Use Problem
93
93
Fracture
40
40
Malposition of Device
21
21
Device Dislodged or Dislocated
21
21
Activation, Positioning or Separation Problem
16
16
Device Difficult to Setup or Prepare
13
13
Migration or Expulsion of Device
11
11
Device Damaged by Another Device
11
11
Device Contamination with Chemical or Other Material
11
11
Component Missing
8
8
Material Deformation
6
6
Difficult to Insert
4
4
Defective Device
3
3
Misfire
3
3
Device Displays Incorrect Message
3
3
Failure to Unfold or Unwrap
2
2
Burst Container or Vessel
1
1
Material Integrity Problem
1
1
Failure to Power Up
1
1
Use of Device Problem
1
1
Material Twisted/Bent
1
1
Detachment of Device or Device Component
1
1
Complete Loss of Power
1
1
Fluid/Blood Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
136
136
Insufficient Information
77
77
No Consequences Or Impact To Patient
30
30
Injury
19
19
Rupture
19
19
Pain
15
15
Obstruction/Occlusion
15
15
Aneurysm
13
13
Ischemia
12
12
Device Embedded In Tissue or Plaque
11
11
Hemorrhage/Bleeding
11
11
Renal Failure
11
11
Unspecified Infection
10
10
Stroke/CVA
7
7
Vascular Dissection
7
7
Embolism/Embolus
7
7
Thrombosis/Thrombus
5
5
Cardiac Arrest
5
5
Anemia
5
5
Hematoma
4
4
Fistula
4
4
Myocardial Infarction
4
4
Multiple Organ Failure
3
3
Respiratory Failure
3
3
Low Blood Pressure/ Hypotension
3
3
Stenosis
3
3
Abdominal Pain
2
2
Intimal Dissection
2
2
Confusion/ Disorientation
2
2
Fever
2
2
Constipation
2
2
Diarrhea
2
2
Air Embolism
2
2
Dyspnea
2
2
Arrhythmia
2
2
Unspecified Tissue Injury
2
2
Death
2
2
Thrombus
1
1
Wound Dehiscence
1
1
Unspecified Respiratory Problem
1
1
Ruptured Aneurysm
1
1
Pseudoaneurysm
1
1
Embolism
1
1
Swelling/ Edema
1
1
Anxiety
1
1
Extravasation
1
1
Heart Failure/Congestive Heart Failure
1
1
Pneumonia
1
1
Renal Impairment
1
1
Pulmonary Dysfunction
1
1
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