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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, vascular graft, of less then 6mm diameter
Regulation Description Vascular graft prosthesis.
Product CodeDYF
Regulation Number 870.3450
Device Class 2

MDR Year MDR Reports MDR Events
2021 5 5
2022 9 10
2023 8 8
2024 6 6
2025 4 4
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 6 6
Mechanical Problem 5 6
Material Separation 4 4
Material Split, Cut or Torn 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Patient Device Interaction Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Separation Failure 2 2
Device Stenosis 2 2
Infusion or Flow Problem 2 2
Material Too Rigid or Stiff 2 2
Improper or Incorrect Procedure or Method 2 2
Break 1 1
Crack 1 1
Material Frayed 1 1
Material Integrity Problem 1 1
Peeled/Delaminated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 22
Insufficient Information 6 7
Thrombosis/Thrombus 5 5
Hemorrhage/Blood Loss/Bleeding 2 2
Stenosis 2 2
Pulmonary Hypertension 2 2
Unspecified Tissue Injury 1 1
Granuloma 1 1
Failure of Implant 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Inflammation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Jun-04-2024
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