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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device absorbable coronary drug-eluting stent
Definition An absorbable scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
Product CodePNY
Device Class 3

MDR Year MDR Reports MDR Events
2021 23 23
2022 7 7
2023 10 10
2024 4 4
2025 16 16
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 53 53
Patient-Device Incompatibility 6 6
Break 2 2
Failure to Advance 2 2
Difficult to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Thrombosis/Thrombus 24 24
Myocardial Infarction 20 20
Stenosis 15 15
Death 7 7
No Clinical Signs, Symptoms or Conditions 7 7
Thrombosis 7 7
Angina 6 6
Aneurysm 5 5
Ischemia 4 4
Perforation of Vessels 4 4
Stroke/CVA 3 3
Hematoma 2 2
Perforation 2 2
Obstruction/Occlusion 2 2
Cardiac Tamponade 2 2
Unspecified Heart Problem 2 2
Low Blood Pressure/ Hypotension 2 2
Non specific EKG/ECG Changes 1 1
Arrhythmia 1 1
Pericardial Effusion 1 1
Cardiac Arrest 1 1
Transient Ischemic Attack 1 1
Heart Failure/Congestive Heart Failure 1 1
Pseudoaneurysm 1 1
No Consequences Or Impact To Patient 1 1
Unspecified Vascular Problem 1 1
Hemorrhage/Bleeding 1 1

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