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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device stent graft, bypass, superficial femoral artery
Definition For bypassing stenosis in the superficial femoral artery via the femoral vein
Product CodeQWM
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
0 0 0 2 1 0

MDR Year MDR Reports MDR Events
2023 1 1
2024 16 16
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Complete Blockage 4 4
Migration 3 3
Device Stenosis 3 3
Failure to Unfold or Unwrap 2 2
Difficult to Remove 2 2
Activation Failure 2 2
Obstruction of Flow 2 2
Malposition of Device 2 2
Partial Blockage 1 1
Detachment of Device or Device Component 1 1
Migration or Expulsion of Device 1 1
Difficult to Advance 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Lack of Effect 1 1
Noise, Audible 1 1
Device Dislodged or Dislocated 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Obstruction/Occlusion 8 8
Pain 6 6
No Clinical Signs, Symptoms or Conditions 4 4
Thrombosis/Thrombus 3 3
Insufficient Information 2 2
Necrosis 1 1
Stenosis 1 1
Sepsis 1 1
Failure of Implant 1 1

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