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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
Product CodeDYF
Regulation Number 870.3450
Device Class 2

MDR Year MDR Reports MDR Events
2015 12 12
2016 35 35
2017 18 18
2018 6 6
2019 5 5
2020 7 7
2021 5 5
2022 9 9
2023 8 8
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Torn Material 34 34
Leak/Splash 18 18
Adverse Event Without Identified Device or Use Problem 11 11
Material Split, Cut or Torn 8 8
Mechanical Problem 5 5
Obstruction of Flow 5 5
Material Separation 4 4
Occlusion Within Device 3 3
Material Perforation 3 3
Degraded 2 2
Material Deformation 2 2
Device Contamination with Chemical or Other Material 2 2
Device Markings/Labelling Problem 2 2
Split 2 2
Material Too Rigid or Stiff 2 2
Infusion or Flow Problem 2 2
Fluid/Blood Leak 2 2
Hole In Material 2 2
Compatibility Problem 1 1
Material Frayed 1 1
Cut In Material 1 1
Contamination /Decontamination Problem 1 1
Patient Device Interaction Problem 1 1
Material Fragmentation 1 1
Material Rupture 1 1
Packaging Problem 1 1
Device Reprocessing Problem 1 1
Component Misassembled 1 1
Break 1 1
Peeled/Delaminated 1 1
Crack 1 1
Insufficient Information 1 1
Complete Blockage 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Device Operates Differently Than Expected 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 26 26
No Consequences Or Impact To Patient 23 23
No Known Impact Or Consequence To Patient 21 21
No Clinical Signs, Symptoms or Conditions 19 19
Insufficient Information 6 6
Unspecified Infection 4 4
Thrombosis 4 4
Stenosis 4 4
No Information 3 3
Thrombosis/Thrombus 3 3
Pseudoaneurysm 3 3
Hematoma 2 2
Fever 2 2
Hemorrhage/Bleeding 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
Sepsis 1 1
Failure of Implant 1 1
Occlusion 1 1
Inflammation 1 1
Post Operative Wound Infection 1 1
Seroma 1 1
Chills 1 1
Injury 1 1
Vomiting 1 1
Fluid Discharge 1 1
Unspecified Tissue Injury 1 1
Tissue Damage 1 1
Erosion 1 1
Thrombus 1 1
Low Blood Pressure/ Hypotension 1 1
Tissue Breakdown 1 1
Granuloma 1 1

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