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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
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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