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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 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 134 134
Adverse Event Without Identified Device or Use Problem 82 82
Fracture 46 46
Activation, Positioning or Separation Problem 23 23
Malposition of Device 20 20
Device Difficult to Setup or Prepare 17 17
Device Dislodged or Dislocated 15 15
Device Damaged by Another Device 12 12
Misfire 10 10
Component Missing 9 9
Device Displays Incorrect Message 8 8
Material Deformation 6 6
Migration or Expulsion of Device 4 4
Difficult to Insert 4 4
Difficult to Remove 2 2
Failure to Unfold or Unwrap 2 2
Detachment of Device or Device Component 2 2
Device Contamination with Chemical or Other Material 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
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 150 150
Insufficient Information 78 78
Obstruction/Occlusion 16 16
Renal Failure 13 13
Device Embedded In Tissue or Plaque 12 12
Hemorrhage/Bleeding 12 12
Ischemia 12 12
Rupture 12 12
Pain 12 12
Unspecified Infection 11 11
Vascular Dissection 10 10
Aneurysm 8 8
Stroke/CVA 7 7
Embolism/Embolus 6 6
Multiple Organ Failure 5 5
Myocardial Infarction 5 5
Fistula 4 4
Cardiac Arrest 4 4
Thrombosis/Thrombus 4 4
Pneumonia 4 4
Respiratory Failure 3 3
Hematoma 3 3
Stenosis 3 3
Air Embolism 2 2
Constipation 2 2
Anemia 2 2
Confusion/ Disorientation 2 2
Fever 2 2
Hemothorax 1 1
Unspecified Respiratory Problem 1 1
Ruptured Aneurysm 1 1
Pseudoaneurysm 1 1
Swelling/ Edema 1 1
Unspecified Tissue Injury 1 1
Anxiety 1 1
Shock 1 1
Extravasation 1 1
Heart Failure/Congestive Heart Failure 1 1
Renal Impairment 1 1
Dyspnea 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Numbness 1 1
Jaundice 1 1
Diarrhea 1 1
Peripheral Edema 1 1
Muscle Weakness 1 1
Nausea 1 1
Fatigue 1 1
Pulmonary Dysfunction 1 1
Arrhythmia 1 1

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