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TPLC
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Device
left atrial appendage clip, implantable
Definition
Intended to occlude the left atrial appendage.
Product Code
PZX
Regulation Number
878.4300
Device Class
2
Premarket Reviews
Manufacturer
Decision
ATRICURE, INC
SUBSTANTIALLY EQUIVALENT
1
ATRICURE, INC.
SUBSTANTIALLY EQUIVALENT
4
SYNTHEON
SUBSTANTIALLY EQUIVALENT
1
SYNTHEON, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2021
10
10
2022
14
14
2023
9
9
2024
20
20
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
24
24
Malposition of Device
7
7
Mechanical Problem
5
5
Use of Device Problem
3
3
Fluid/Blood Leak
2
2
Separation Problem
1
1
Activation, Positioning or Separation Problem
1
1
Device Markings/Labelling Problem
1
1
Positioning Problem
1
1
Difficult to Remove
1
1
Positioning Failure
1
1
Packaging Problem
1
1
Misassembled
1
1
Migration
1
1
Tear, Rip or Hole in Device Packaging
1
1
Appropriate Term/Code Not Available
1
1
Mechanical Jam
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Cardiac Perforation
11
11
Hemorrhage/Bleeding
10
10
No Clinical Signs, Symptoms or Conditions
7
7
Ventricular Fibrillation
5
5
Obstruction/Occlusion
3
3
Thrombosis/Thrombus
3
3
Perforation
2
2
Tachycardia
2
2
Stenosis
2
2
Unspecified Tissue Injury
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Non specific EKG/ECG Changes
1
1
High Blood Pressure/ Hypertension
1
1
Stroke/CVA
1
1
Arrhythmia
1
1
Pericardial Effusion
1
1
Cardiac Arrest
1
1
Insufficient Information
1
1
Great Vessel Perforation
1
1
Loss of consciousness
1
1
Ischemia Stroke
1
1
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