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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
2021 59 59
2022 52 52
2023 52 52
2024 62 62
2025 56 56
2026 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 135 135
Adverse Event Without Identified Device or Use Problem 83 83
Fracture 48 48
Activation, Positioning or Separation Problem 26 26
Malposition of Device 21 21
Device Difficult to Setup or Prepare 16 16
Device Dislodged or Dislocated 15 15
Misfire 12 12
Device Damaged by Another Device 12 12
Component Missing 11 11
Device Displays Incorrect Message 9 9
Material Deformation 6 6
Migration or Expulsion of Device 4 4
Difficult to Insert 4 4
Failure to Unfold or Unwrap 2 2
Device Contamination with Chemical or Other Material 2 2
Detachment of Device or Device Component 2 2
Difficult to Remove 2 2
Material Twisted/Bent 1 1
Complete Loss of Power 1 1
Failure to Power Up 1 1
Material Integrity Problem 1 1
Fluid/Blood Leak 1 1
Use of Device Problem 1 1
Burst Container or Vessel 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 157 157
Insufficient Information 79 79
Obstruction/Occlusion 17 17
Renal Failure 14 14
Ischemia 13 13
Unspecified Infection 12 12
Hemorrhage/Blood Loss/Bleeding 12 12
Rupture 12 12
Pain 12 12
Device Embedded In Tissue or Plaque 12 12
Vascular Dissection 11 11
Aneurysm 8 8
Stroke/CVA 8 8
Myocardial Infarction 6 6
Embolism/Embolus 6 6
Pneumonia 5 5
Multiple Organ Dysfunction Syndrome 5 5
Respiratory Failure 4 4
Aneurysm expansion 4 4
Cardiac Arrest 4 4
Thrombosis/Thrombus 4 4
Hematoma 4 4
Fistula 4 4
Stenosis 3 3
Delirium 2 2
Confusion/ Disorientation 2 2
Fever 2 2
Kidney injury 2 2
Air Embolism 2 2
Constipation 2 2
Anemia 2 2
Shock 2 2
Dyspnea 1 1
Anxiety 1 1
Aortic dissection 1 1
Renal Impairment 1 1
Pseudoaneurysm 1 1
Extravasation 1 1
Wound Dehiscence 1 1
Jaundice 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Ruptured Aneurysm 1 1
Diarrhea 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Fatigue 1 1
Numbness 1 1
Peripheral Edema 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Nausea 1 1

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