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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device embolization agent, vascular
Definition For occluding peripheral vessels
Product CodeQVG
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 0 3 1 7 2

MDR Year MDR Reports MDR Events
2024 2 2
2025 16 16
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 5 5
Failure to Transmit Record 4 4
No Apparent Adverse Event 2 2
Device Dislodged or Dislocated 2 2
Device-Device Incompatibility 1 1
Off-Label Use 1 1
Physical Resistance/Sticking 1 1
Short Fill 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Failure to Deliver 1 1
Device Difficult to Setup or Prepare 1 1
Infusion or Flow Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Ambient Temperature Problem 1 1
Detachment of Device or Device Component 1 1
Overheating of Device 1 1
Display or Visual Feedback Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
High Blood Pressure/ Hypertension 1 1
Myocardial Infarction 1 1
Pain 1 1
Urticaria 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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