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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
2014 7 7
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
Obstruction of Flow 5 5
Mechanical Problem 5 5
Material Separation 4 4
Device Contamination with Chemical or Other Material 3 3
Material Perforation 3 3
Split 3 3
Occlusion Within Device 3 3
Degraded 2 2
Infusion or Flow Problem 2 2
Device Operates Differently Than Expected 2 2
Fluid/Blood Leak 2 2
Device Markings/Labelling Problem 2 2
Material Deformation 2 2
Material Too Rigid or Stiff 2 2
Hole In Material 2 2
Patient Device Interaction Problem 1 1
Complete Blockage 1 1
Material Fragmentation 1 1
Detachment Of Device Component 1 1
Peeled/Delaminated 1 1
Moisture or Humidity Problem 1 1
Material Rupture 1 1
Defective Device 1 1
Break 1 1
Insufficient Information 1 1
Cut In Material 1 1
Packaging Problem 1 1
Crack 1 1
Device Reprocessing Problem 1 1
Failure To Adhere Or Bond 1 1
Compatibility Problem 1 1
Material Integrity Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Dislodged or Dislocated 1 1
Material Puncture/Hole 1 1
Delamination 1 1
Contamination /Decontamination Problem 1 1
Material Frayed 1 1
Component Misassembled 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 23 23
No Clinical Signs, Symptoms or Conditions 19 19
Insufficient Information 6 6
No Information 6 6
Stenosis 4 4
Unspecified Infection 4 4
Thrombosis 4 4
Pseudoaneurysm 3 3
Thrombosis/Thrombus 3 3
Fever 2 2
Sepsis 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Inflammation 1 1
Occlusion 1 1
Renal Failure 1 1
Seroma 1 1
Swelling 1 1
Granuloma 1 1
Thrombus 1 1
Tissue Damage 1 1
Vomiting 1 1
Chills 1 1
Unspecified Tissue Injury 1 1
No Code Available 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Erosion 1 1
Tissue Breakdown 1 1
Fluid Discharge 1 1
Injury 1 1
Post Operative Wound Infection 1 1
Respiratory Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Sep-30-2013
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