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TPLC
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show TPLC since
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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
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
Occlusion Within Device
3
3
Material Perforation
3
3
Device Markings/Labelling Problem
2
2
Split
2
2
Degraded
2
2
Material Too Rigid or Stiff
2
2
Infusion or Flow Problem
2
2
Material Deformation
2
2
Fluid/Blood Leak
2
2
Hole In Material
2
2
Device Contamination with Chemical or Other Material
2
2
Cut In Material
1
1
Material Frayed
1
1
Compatibility Problem
1
1
Crack
1
1
Peeled/Delaminated
1
1
Material Fragmentation
1
1
Improper or Incorrect Procedure or Method
1
1
Packaging Problem
1
1
Material Rupture
1
1
Device Operates Differently Than Expected
1
1
Break
1
1
Insufficient Information
1
1
Complete Blockage
1
1
Material Integrity Problem
1
1
Defective Device
1
1
Contamination /Decontamination Problem
1
1
Patient Device Interaction Problem
1
1
Component Misassembled
1
1
Device Reprocessing Problem
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
Failure of Implant
1
1
Sepsis
1
1
No Code Available
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
Granuloma
1
1
Low Blood Pressure/ Hypotension
1
1
Thrombus
1
1
Tissue Breakdown
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
II
Jun-04-2024
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