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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 9

MDR Year MDR Reports MDR Events
2024 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 28 28
Malposition of Device 17 17
Central Regurgitation 5 5
Migration 4 4
Difficult to Insert 3 3
Perivalvular Leak 2 2
Particulates 2 2
Device-Device Incompatibility 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Heart Block 18 18
Failure of Implant 12 12
Cardiac Perforation 5 5
Thrombosis/Thrombus 5 5
Heart Failure/Congestive Heart Failure 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Cardiac Tamponade 3 3
Bradycardia 3 3
Arrhythmia 2 2
Hemolysis 2 2
Great Vessel Perforation 2 2
Hemolytic Anemia 1 1
Retroperitoneal Hemorrhage 1 1
Cardiogenic Shock 1 1
Dyspnea 1 1
Perforation of Vessels 1 1

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