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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 2026
0 0 0 2 1 5 1

MDR Year MDR Reports MDR Events
2023 1 1
2024 16 16
2025 8 8
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Complete Blockage 5 5
Migration 4 4
Device Stenosis 4 4
Obstruction of Flow 3 3
Malposition of Device 3 3
Activation Failure 3 3
Unintended Movement 3 3
Migration or Expulsion of Device 2 2
Failure to Unfold or Unwrap 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Noise, Audible 2 2
Difficult to Remove 2 2
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Device Dislodged or Dislocated 1 1
Difficult to Advance 1 1
Lack of Effect 1 1
Partial Blockage 1 1
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Difficult or Delayed Activation 1 1
Insufficient Device Problem Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Obstruction/Occlusion 10 10
No Clinical Signs, Symptoms or Conditions 7 7
Pain 7 7
Thrombosis/Thrombus 5 5
Ischemia 3 3
Insufficient Information 2 2
Stenosis 2 2
Failure of Implant 2 2
Retroperitoneal Hemorrhage 1 1
Sepsis 1 1
Fistula 1 1
Necrosis 1 1
Exsanguination 1 1
Hematoma 1 1
Respiratory Failure 1 1

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