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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 0 0 0 0 4 3 2

MDR Year MDR Reports MDR Events
2022 11 11
2023 26 26
2024 42 96

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 35 54
Adverse Event Without Identified Device or Use Problem 26 33
Obstruction of Flow 5 34
Material Deformation 5 5
Appropriate Term/Code Not Available 5 10
Defective Device 4 4
Material Twisted/Bent 3 3
Deformation Due to Compressive Stress 3 3
Contamination /Decontamination Problem 2 2
Activation, Positioning or Separation Problem 1 1
Patient-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult or Delayed Activation 1 1
Device Handling Problem 1 1
Difficult or Delayed Separation 1 2
Fracture 1 1
Device Dislodged or Dislocated 1 1
Product Quality Problem 1 1
Migration 1 1
Inadequacy of Device Shape and/or Size 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 26
Thrombosis/Thrombus 13 13
Insufficient Information 12 12
Stroke/CVA 10 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Hemorrhage/Bleeding 5 5
Vascular Dissection 4 33
Paraplegia 4 4
Hematoma 3 5
Obstruction/Occlusion 3 3
High Blood Pressure/ Hypertension 2 2
Ischemia 2 2
Renal Impairment 2 2
Aneurysm 2 2
Pulmonary Hypertension 1 1
Unspecified Infection 1 1
Sepsis 1 1
Fungal Infection 1 3
Perforation of Esophagus 1 1
Diminished Pulse Pressure 1 1
Embolism/Embolus 1 1
Atrial Fibrillation 1 1
Anemia 1 1
Rupture 1 1
Fever 1 1
Cardiogenic Shock 1 1
Pseudoaneurysm 1 1
Bacterial Infection 1 3
Thromboembolism 1 3
Low Blood Pressure/ Hypotension 1 1

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