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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hybrid stent graft, thoracic aortic lesion treatment
Definition Repair or replacement of damaged or diseased vessel of the aortic arch and descending thoracic aorta, with or without involvement of ascending aorta, using vascular grafts and/or stent grafts placed during open surgical repair.
Product CodeQSK
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 4 3 2 6 1

MDR Year MDR Reports MDR Events
2022 11 12
2023 26 27
2024 58 112
2025 172 172
2026 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 154 163
Insufficient Information 104 123
Obstruction of Flow 8 37
Deformation Due to Compressive Stress 7 7
Fluid/Blood Leak 7 7
Patient-Device Incompatibility 6 6
Material Deformation 6 6
Appropriate Term/Code Not Available 6 11
Defective Device 5 5
Device Stenosis 4 4
Material Integrity Problem 4 4
Material Twisted/Bent 4 4
Device-Device Incompatibility 2 2
Off-Label Use 2 2
Contamination /Decontamination Problem 2 2
Migration 2 2
Fracture 2 2
Human-Device Interface Problem 2 2
Leak/Splash 1 1
Activation, Positioning or Separation Problem 1 1
Expiration Date Error 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1
Patient Device Interaction Problem 1 1
Material Fragmentation 1 1
Backflow 1 1
Difficult or Delayed Activation 1 1
Device Handling Problem 1 1
Difficult or Delayed Separation 1 2
Partial Blockage 1 1
Product Quality Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Detachment of Device or Device Component 1 1
Installation-Related Problem 1 1
Device Dislodged or Dislocated 1 2
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 35 36
No Clinical Signs, Symptoms or Conditions 31 37
Thrombosis/Thrombus 29 30
Stroke/CVA 29 48
Hemorrhage/Bleeding 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Paraplegia 10 10
Aneurysm 10 10
Pericardial Effusion 9 9
Ischemia 8 8
Unspecified Infection 7 7
Pseudoaneurysm 7 7
Obstruction/Occlusion 7 8
Stenosis 7 7
Vascular Dissection 6 35
Hematoma 6 8
High Blood Pressure/ Hypertension 5 5
Anemia 5 5
Atrial Fibrillation 4 4
Bacterial Infection 4 6
Paresis 4 4
Renal Impairment 4 4
Unspecified Heart Problem 3 3
Ruptured Aneurysm 3 3
Embolism/Embolus 3 3
Rupture 3 3
Pleural Effusion 3 3
Paralysis 3 3
Sepsis 3 3
Transient Ischemic Attack 3 3
Cardiac Arrest 2 2
Pulmonary Embolism 2 2
Fever 2 2
Dysphagia/ Odynophagia 2 2
Respiratory Insufficiency 2 2
Unspecified Vascular Problem 2 2
Heart Failure/Congestive Heart Failure 2 2
Thromboembolism 2 4
Peripheral Edema 1 1
Valvular Insufficiency/ Regurgitation 1 1
Liver Failure 1 1
Pulmonary Hypertension 1 1
Cardiac Tamponade 1 1
Cardiogenic Shock 1 1
Perforation of Esophagus 1 1
Fungal Infection 1 3
Post Traumatic Wound Infection 1 1
Ischemic Heart Disease 1 1
Ischemia Stroke 1 1
Thrombocytopenia 1 1

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