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TPLC
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Device
prosthesis, vascular graft, of less then 6mm diameter
Product Code
DYF
Regulation Number
870.3450
Device Class
2
MDR Year
MDR Reports
MDR Events
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
Leak/Splash
6
6
Obstruction of Flow
5
5
Material Split, Cut or Torn
5
5
Mechanical Problem
5
5
Adverse Event Without Identified Device or Use Problem
4
4
Material Separation
4
4
Material Too Rigid or Stiff
2
2
Device Markings/Labelling Problem
2
2
Infusion or Flow Problem
2
2
Material Deformation
2
2
Patient Device Interaction Problem
1
1
Material Frayed
1
1
Break
1
1
Peeled/Delaminated
1
1
Crack
1
1
Complete Blockage
1
1
Material Integrity Problem
1
1
Defective Device
1
1
Component Misassembled
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
19
19
Insufficient Information
6
6
Stenosis
4
4
No Known Impact Or Consequence To Patient
3
3
Thrombosis/Thrombus
3
3
Thrombosis
3
3
Hemorrhage/Bleeding
2
2
Unspecified Infection
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Failure of Implant
1
1
No Information
1
1
Occlusion
1
1
Inflammation
1
1
Injury
1
1
Unspecified Tissue Injury
1
1
Tissue Damage
1
1
Granuloma
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
II
Jun-04-2024
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