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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

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021 2022 2023 2024
5 4 1 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2016 224 224
2017 328 328
2018 105 105
2019 38 38
2020 168 168
2021 23 23
2022 7 7
2023 10 10
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 791 791
Improper or Incorrect Procedure or Method 42 42
Difficult or Delayed Positioning 26 26
Patient-Device Incompatibility 25 25
Break 9 9
Detachment Of Device Component 9 9
Difficult or Delayed Activation 6 6
Material Rupture 6 6
Difficult To Position 6 6
Failure to Advance 6 6
Device Operates Differently Than Expected 6 6
Positioning Failure 5 5
Difficult to Remove 4 4
Physical Resistance 4 4
Material Deformation 4 4
Off-Label Use 3 3
Inflation Problem 3 3
Product Quality Problem 3 3
Device Expiration Issue 2 2
Material Too Rigid or Stiff 2 2
Device Damaged by Another Device 2 2
Device Contaminated During Manufacture or Shipping 1 1
Migration or Expulsion of Device 1 1
Malposition of Device 1 1
Kinked 1 1
Material Separation 1 1
Migration 1 1
Device Dislodged or Dislocated 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Thrombosis 424 424
Angina 308 308
Myocardial Infarction 306 306
Stenosis 282 282
Death 100 100
Aneurysm 43 43
Intimal Dissection 42 42
No Consequences Or Impact To Patient 33 33
Ischemia 33 33
Cardiac Arrest 27 27
Dyspnea 26 26
Perforation 24 24
Non specific EKG/ECG Changes 23 23
Cardiac Enzyme Elevation 23 23
Occlusion 20 20
Thrombosis/Thrombus 14 14
Prolapse 12 12
Test Result 12 12
Low Blood Pressure/ Hypotension 10 10
Heart Failure 9 9
Respiratory Failure 8 8
Ventricular Fibrillation 8 8
Arrhythmia 8 8
Stroke/CVA 8 8
Hemorrhage/Bleeding 7 7
Hematoma 7 7
No Patient Involvement 7 7
Diaphoresis 6 6
Ventricular Tachycardia 5 5
Atrial Fibrillation 5 5
Cardiogenic Shock 5 5
Embolism 4 4
Perforation of Vessels 4 4
No Clinical Signs, Symptoms or Conditions 4 4
No Information 4 4
Cardiac Tamponade 3 3
Nausea 3 3
Bradycardia 3 3
Renal Failure 3 3
Hypersensitivity/Allergic reaction 3 3
Dyskinesia 3 3
Foreign Body In Patient 2 2
No Code Available 2 2
Respiratory Distress 2 2
Sepsis 2 2
Coma 2 2
Pulmonary Edema 2 2
Tachycardia 2 2
Pseudoaneurysm 2 2
High Blood Pressure/ Hypertension 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular I Jun-01-2017
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