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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
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
Material Perforation
3
3
Occlusion Within Device
3
3
Device Markings/Labelling Problem
2
2
Split
2
2
Degraded
2
2
Infusion or Flow Problem
2
2
Fluid/Blood Leak
2
2
Hole In Material
2
2
Material Too Rigid or Stiff
2
2
Material Deformation
2
2
Device Contamination with Chemical or Other Material
2
2
Compatibility Problem
1
1
Material Frayed
1
1
Cut In Material
1
1
Break
1
1
Crack
1
1
Peeled/Delaminated
1
1
Complete Blockage
1
1
Insufficient Information
1
1
Defective Device
1
1
Material Integrity Problem
1
1
Material Fragmentation
1
1
Device Operates Differently Than Expected
1
1
Material Rupture
1
1
Packaging Problem
1
1
Component Misassembled
1
1
Device Reprocessing Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Contamination /Decontamination Problem
1
1
Patient Device Interaction 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
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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