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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)
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 3

MDR Year MDR Reports MDR Events
2024 99 99

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 58 58
Material Rupture 30 30
Failure to Advance 11 11
Break 6 6
Material Deformation 6 6
Entrapment of Device 5 5
Difficult to Advance 5 5
Inflation Problem 3 3
Leak/Splash 2 2
Difficult to Remove 2 2
Detachment of Device or Device Component 2 2
Physical Resistance/Sticking 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 53 53
Restenosis 22 22
Angina 9 9
Myocardial Infarction 7 7
Ischemia 6 6
Cardiac Arrest 6 6
Vascular Dissection 5 5
Chest Pain 5 5
Thrombosis/Thrombus 3 3
Insufficient Information 3 3
Dyspnea 3 3
Non specific EKG/ECG Changes 2 2
Hematoma 2 2
Atrial Fibrillation 2 2
Heart Failure/Congestive Heart Failure 2 2
Air Embolism 1 1
Arrhythmia 1 1
Obstruction/Occlusion 1 1
Unspecified Heart Problem 1 1

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