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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 1

MDR Year MDR Reports MDR Events
2022 11 11
2023 26 26
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 21 21
Adverse Event Without Identified Device or Use Problem 12 12
Appropriate Term/Code Not Available 4 4
Defective Device 3 3
Material Deformation 2 2
Contamination /Decontamination Problem 2 2
Material Twisted/Bent 2 2
Patient-Device Incompatibility 1 1
Fracture 1 1
Migration 1 1
Device Dislodged or Dislocated 1 1
Activation, Positioning or Separation Problem 1 1
Obstruction of Flow 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Handling Problem 1 1
Difficult or Delayed Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
Insufficient Information 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Thrombosis/Thrombus 7 7
Stroke/CVA 4 4
Obstruction/Occlusion 2 2
Hematoma 2 2
Hemorrhage/Bleeding 1 1
Unspecified Infection 1 1
Pulmonary Hypertension 1 1
Renal Impairment 1 1
Diminished Pulse Pressure 1 1
Vascular Dissection 1 1
Embolism/Embolus 1 1
Fever 1 1
Anemia 1 1
Atrial Fibrillation 1 1

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