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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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 36 36
Insufficient Information 10 10
Patient-Device Incompatibility 8 8
Obstruction of Flow 6 6
Patient Device Interaction Problem 5 5
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
Premature Activation 1 1
Improper or Incorrect Procedure or Method 1 1
Material Deformation 1 1
Positioning Problem 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Malposition of Device 1 1
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Difficult to Advance 1 1
Complete Blockage 1 1
Difficult or Delayed Positioning 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Ischemia 15 15
No Clinical Signs, Symptoms or Conditions 13 13
Vascular Dissection 10 10
Paralysis 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Obstruction/Occlusion 6 6
Renal Impairment 5 5
Stroke/CVA 4 4
Insufficient Information 4 4
Aneurysm 4 4
Anemia 3 3
Movement Disorder 3 3
Thrombosis/Thrombus 3 3
Renal Failure 3 3
Paraplegia 3 3
Ischemia Stroke 3 3
Embolism/Embolus 2 2
Low Blood Pressure/ Hypotension 2 2
Abdominal Pain 1 1
Coagulation Disorder 1 1
Hematoma 1 1
Rupture 1 1
Hemorrhagic Stroke 1 1
Foreign Body Embolism 1 1
Paresis 1 1
Perforation of Vessels 1 1
Shock 1 1
Pseudoaneurysm 1 1
Thromboembolism 1 1
Hemorrhage/Bleeding 1 1
Respiratory Failure 1 1
Internal Organ Perforation 1 1

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