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TPLC
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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 Code
PNY
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
Device Operates Differently Than Expected
6
6
Failure to Advance
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
Malposition of Device
1
1
Migration or Expulsion of Device
1
1
Kinked
1
1
Migration
1
1
Material Separation
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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