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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stent graft, infrapopliteal, venous arterialization
Definition For performing percutaneous arterialization of the deep veins to restore blood flow in the lower limbs
Product CodeQWN
Device Class 3

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

MDR Year MDR Reports MDR Events
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 3 3
Stretched 1 1
Mechanical Jam 1 1
Therapy Delivered to Incorrect Body Area 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Failure of Implant 1 1

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