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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, percutaneous (valvuloplasty)
Product CodeMAD
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 1 0 0 0 0 0 0 1 0 1 1 0 0 0

MDR Year MDR Reports MDR Events
2015 1 1
2018 3 3
2019 1 1
2020 1 1
2021 1 1
2022 4 4
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Burst Container or Vessel 1 1
Material Fragmentation 1 1
Material Rupture 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Mitral Valve Insufficiency/ Regurgitation 6 6
Tissue Breakdown 2 2
No Known Impact Or Consequence To Patient 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Insufficiency, Valvular 1 1
Mitral Regurgitation 1 1
Ventricular Tachycardia 1 1
Rupture 1 1
Cardiac Tamponade 1 1
Mitral Perforation 1 1

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