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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drug-eluting percutaneous transluminal coronary angioplasty catheter
Definition A drug-eluting percutaneous transluminal coronary angioplasty catheter is a combination product intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A drug-eluting ptca catheter may also be intended for the treatment of acute myocardial infarction; Treatment of in-stent restenosis (isr) and/or post-deployment stent expansion. A drug-eluting ptca catheter delivers a drug to the vessel as part of the angioplasty procedure, which is intended to inhibit restenosis.
Product CodeOOB
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 0 2

MDR Year MDR Reports MDR Events
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 11 11
Adverse Event Without Identified Device or Use Problem 4 4
Failure to Advance 2 2
Material Deformation 2 2
Break 2 2
Entrapment of Device 1 1
Inflation Problem 1 1
Leak/Splash 1 1
Material Integrity Problem 1 1
Difficult to Advance 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Cardiac Arrest 2 2
Ischemia 1 1
Insufficient Information 1 1
Air Embolism 1 1

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