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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
Definition Endovascular repair of thoracoabdominal and pararenal aortic lesions
Product CodeQZK
Device Class 3

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

MDR Year MDR Reports MDR Events
2024 16 16
2025 69 69
2026 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 40 40
Insufficient Information 10 10
Patient-Device Incompatibility 8 8
Obstruction of Flow 8 8
Patient Device Interaction Problem 7 7
No Apparent Adverse Event 4 4
Fracture 4 4
Appropriate Term/Code Not Available 3 3
Use of Device Problem 2 2
Migration 2 2
Fluid/Blood Leak 2 2
Malposition of Device 1 1
Complete Blockage 1 1
Difficult to Advance 1 1
Positioning Problem 1 1
Positioning Failure 1 1
Device Damaged by Another Device 1 1
Difficult or Delayed Positioning 1 1
Material Deformation 1 1
Device Handling Problem 1 1
Partial Blockage 1 1
Detachment of Device or Device Component 1 1
Activation Failure 1 1
Improper or Incorrect Procedure or Method 1 1
Premature Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Ischemia 17 17
No Clinical Signs, Symptoms or Conditions 13 13
Vascular Dissection 10 10
Paralysis 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Renal Impairment 6 6
Obstruction/Occlusion 6 6
Paraplegia 4 4
Anemia 4 4
Aneurysm 4 4
Stroke/CVA 4 4
Insufficient Information 4 4
Movement Disorder 4 4
Thrombosis/Thrombus 4 4
Ischemia Stroke 3 3
Renal Failure 3 3
Low Blood Pressure/ Hypotension 2 2
Embolism/Embolus 2 2
Paresis 2 2
Hemorrhagic Stroke 1 1
Foreign Body Embolism 1 1
Abdominal Pain 1 1
Internal Organ Perforation 1 1
Coagulation Disorder 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Shock 1 1
Perforation of Vessels 1 1
Rupture 1 1
Stenosis 1 1
Respiratory Failure 1 1
Pseudoaneurysm 1 1
Thromboembolism 1 1

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