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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device left atrial appendage clip, implantable
Definition Intended to occlude the left atrial appendage.
Product CodePZX
Regulation Number 878.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
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
Activation, Positioning or Separation Problem 1 1
Separation Problem 1 1
Device Markings/Labelling Problem 1 1
Positioning Problem 1 1
Difficult to Remove 1 1
Positioning Failure 1 1
Misassembled 1 1
Packaging Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Migration 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
Non specific EKG/ECG Changes 1 1
High Blood Pressure/ Hypertension 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Arrhythmia 1 1
Stroke/CVA 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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