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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
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 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 187 187
Adverse Event Without Identified Device or Use Problem 117 117
Fracture 48 48
Malposition of Device 27 27
Device Dislodged or Dislocated 25 25
Device Damaged by Another Device 14 14
Device Contamination with Chemical or Other Material 12 12
Activation, Positioning or Separation Problem 12 12
Migration or Expulsion of Device 10 10
Device Difficult to Setup or Prepare 9 9
Component Missing 8 8
Material Deformation 7 7
Difficult to Insert 5 5
Misfire 4 4
Defective Device 4 4
Detachment of Device or Device Component 4 4
Failure to Unfold or Unwrap 2 2
Use of Device Problem 1 1
Defective Component 1 1
Device Displays Incorrect Message 1 1
Burst Container or Vessel 1 1
Fluid/Blood Leak 1 1
Failure to Power Up 1 1
Premature Activation 1 1
Complete Loss of Power 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 101 101
No Consequences Or Impact To Patient 87 87
Insufficient Information 56 56
Injury 50 50
Rupture 20 20
Pain 20 20
Device Embedded In Tissue or Plaque 17 17
Unspecified Infection 14 14
Ischemia 13 13
Death 13 13
Aneurysm 13 13
Renal Failure 12 12
Obstruction/Occlusion 8 8
Anemia 8 8
Hemorrhage/Bleeding 8 8
Hematoma 7 7
Fever 6 6
Occlusion 6 6
Stroke/CVA 6 6
Abdominal Pain 5 5
Dyspnea 5 5
Respiratory Failure 5 5
Blood Loss 5 5
Embolism/Embolus 4 4
Claudication 4 4
Thrombus 4 4
Low Blood Pressure/ Hypotension 4 4
Intimal Dissection 4 4
Cardiac Arrest 4 4
Myocardial Infarction 3 3
Confusion/ Disorientation 3 3
Thrombosis/Thrombus 3 3
Urinary Retention 2 2
Urinary Tract Infection 2 2
Seroma 2 2
Pleural Effusion 2 2
Atrial Fibrillation 2 2
Air Embolism 2 2
Arrhythmia 2 2
Unspecified Tissue Injury 2 2
Vascular Dissection 2 2
Swelling/ Edema 1 1
Ruptured Aneurysm 1 1
Arthritis 1 1
Aspiration/Inhalation 1 1
Pulmonary Embolism 1 1
Bradycardia 1 1
Chest Pain 1 1
Congestive Heart Failure 1 1
Cyst(s) 1 1
Nausea 1 1
Hyperglycemia 1 1
High Blood Pressure/ Hypertension 1 1
Muscle Weakness 1 1
Embolism 1 1
Fall 1 1
Fatigue 1 1
Diarrhea 1 1
Pulmonary Edema 1 1
Pulmonary Insufficiency 1 1
Tachycardia 1 1
Thrombosis 1 1
Sepsis 1 1
Septic Shock 1 1
Weakness 1 1
Jaundice 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Stenosis 1 1
Anxiety 1 1
Heart Failure/Congestive Heart Failure 1 1
Unspecified Respiratory Problem 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Joint Swelling 1 1
Numbness 1 1
Collapse 1 1

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