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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeOTD
Regulation Number 870.3460
Device Class 2

MDR Year MDR Reports MDR Events
2019 141 141
2020 101 101
2021 59 59
2022 52 52
2023 52 52
2024 62 62
2025 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 232 232
Adverse Event Without Identified Device or Use Problem 150 150
Fracture 57 57
Malposition of Device 36 36
Device Dislodged or Dislocated 27 27
Activation, Positioning or Separation Problem 19 19
Device Damaged by Another Device 17 17
Device Difficult to Setup or Prepare 15 15
Component Missing 12 12
Device Contamination with Chemical or Other Material 12 12
Migration or Expulsion of Device 11 11
Material Deformation 10 10
Misfire 8 8
Device Displays Incorrect Message 7 7
Difficult to Insert 6 6
Defective Device 4 4
Detachment of Device or Device Component 4 4
Failure to Unfold or Unwrap 2 2
Burst Container or Vessel 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Difficult to Remove 1 1
Failure to Power Up 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1
Complete Loss of Power 1 1
Fluid/Blood Leak 1 1
Premature Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 155 155
No Consequences Or Impact To Patient 87 87
Insufficient Information 78 78
Injury 50 50
Rupture 27 27
Pain 22 22
Unspecified Infection 20 20
Renal Failure 18 18
Ischemia 18 18
Device Embedded In Tissue or Plaque 17 17
Obstruction/Occlusion 16 16
Aneurysm 15 15
Hemorrhage/Bleeding 14 14
Death 13 13
Anemia 10 10
Stroke/CVA 9 9
Vascular Dissection 9 9
Respiratory Failure 8 8
Hematoma 8 8
Fever 7 7
Embolism/Embolus 7 7
Abdominal Pain 6 6
Occlusion 6 6
Blood Loss 5 5
Cardiac Arrest 5 5
Confusion/ Disorientation 5 5
Thrombosis/Thrombus 5 5
Myocardial Infarction 5 5
Dyspnea 5 5
Fistula 4 4
Multiple Organ Failure 4 4
Intimal Dissection 4 4
Thrombus 4 4
Low Blood Pressure/ Hypotension 4 4
Claudication 4 4
Arrhythmia 3 3
Stenosis 3 3
Atrial Fibrillation 2 2
Urinary Tract Infection 2 2
Air Embolism 2 2
Seroma 2 2
Constipation 2 2
Diarrhea 2 2
Pleural Effusion 2 2
Urinary Retention 2 2
Unspecified Tissue Injury 2 2
Pneumonia 2 2
Pulmonary Embolism 1 1
Arthritis 1 1
High Blood Pressure/ Hypertension 1 1

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