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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device percutaneously delivered prostheses and tricuspid valves
Definition These devices are intended to replace a patient's tricuspid heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement.
Product CodeNPW
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5

MDR Year MDR Reports MDR Events
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 13 13
Malposition of Device 6 6
Difficult to Insert 2 2
Perivalvular Leak 2 2
Difficult to Remove 1 1
Particulates 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 4 4
Heart Block 4 4
Thrombosis/Thrombus 3 3
Bradycardia 3 3
Cardiac Perforation 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Heart Failure/Congestive Heart Failure 2 2
Retroperitoneal Hemorrhage 1 1
Arrhythmia 1 1
Hemolysis 1 1
Perforation of Vessels 1 1
Great Vessel Perforation 1 1
Cardiac Tamponade 1 1
Cardiogenic Shock 1 1
Hemolytic Anemia 1 1

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