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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)
2019 2020 2021 2022 2023 2024
0 0 0 4 3 1

MDR Year MDR Reports MDR Events
2022 11 11
2023 26 26
2024 17 22

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 22 22
Adverse Event Without Identified Device or Use Problem 16 21
Material Deformation 4 4
Appropriate Term/Code Not Available 4 9
Defective Device 3 3
Contamination /Decontamination Problem 2 2
Material Twisted/Bent 2 2
Device Handling Problem 1 1
Migration 1 1
Activation, Positioning or Separation Problem 1 1
Device Dislodged or Dislocated 1 1
Patient-Device Incompatibility 1 1
Fracture 1 1
Inadequacy of Device Shape and/or Size 1 1
Obstruction of Flow 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 21
Insufficient Information 11 11
Thrombosis/Thrombus 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Stroke/CVA 6 6
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Obstruction/Occlusion 2 2
Renal Impairment 2 2
Paraplegia 1 1
Diminished Pulse Pressure 1 1
Vascular Dissection 1 1
Embolism/Embolus 1 1
Pulmonary Hypertension 1 1
Unspecified Infection 1 1
Ischemia 1 1
Fever 1 1
Anemia 1 1
Atrial Fibrillation 1 1

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