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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stent, coronary
Definition The formerly known device, Cardiovascular Stent, coded as "MAF" has been modified and is currently known and classified as a "Coronary Stent". This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.
Product CodeMAF
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
25 21 13 8 8 2

MDR Year MDR Reports MDR Events
2019 561 561
2020 429 429
2021 329 329
2022 280 280
2023 208 208
2024 64 64

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Advance 856 856
Adverse Event Without Identified Device or Use Problem 257 257
Patient-Device Incompatibility 250 250
Material Deformation 233 233
Improper or Incorrect Procedure or Method 186 186
Device Dislodged or Dislocated 160 160
Material Separation 124 124
Off-Label Use 88 88
Difficult to Advance 88 88
Difficult to Remove 82 82
Deformation Due to Compressive Stress 59 59
Break 34 34
Activation Failure 28 28
Migration 23 23
Fracture 22 22
Positioning Failure 17 17
Defective Device 15 15
Material Split, Cut or Torn 14 14
Material Rupture 12 12
Activation, Positioning or Separation Problem 11 11
No Apparent Adverse Event 10 10
Positioning Problem 10 10
Detachment of Device or Device Component 9 9
Difficult to Insert 9 9
Mechanical Problem 9 9
Deflation Problem 8 8
Premature Activation 8 8
Difficult or Delayed Activation 8 8
Unstable 8 8
Use of Device Problem 7 7
Device Damaged by Another Device 7 7
Leak/Splash 6 6
Inflation Problem 6 6
Therapy Delivered to Incorrect Body Area 5 5
Unintended Movement 5 5
Material Integrity Problem 5 5
Insufficient Information 5 5
Material Twisted/Bent 4 4
Device-Device Incompatibility 4 4
Malposition of Device 4 4
Component Missing 4 4
Product Quality Problem 4 4
Retraction Problem 4 4
Difficult or Delayed Positioning 4 4
Migration or Expulsion of Device 4 4
Entrapment of Device 4 4
Stretched 3 3
Fluid/Blood Leak 2 2
Failure to Fold 2 2
Crack 2 2
Unintended System Motion 2 2
Unsealed Device Packaging 1 1
Loss of or Failure to Bond 1 1
Burst Container or Vessel 1 1
Contamination 1 1
Material Puncture/Hole 1 1
Failure to Deliver 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Slipped 1 1
Device Contamination with Chemical or Other Material 1 1
Device Markings/Labelling Problem 1 1
Material Too Soft/Flexible 1 1
Physical Resistance/Sticking 1 1
Failure to Deflate 1 1
Wrong Label 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 706 706
No Consequences Or Impact To Patient 666 666
Death 71 71
Cardiac Arrest 62 62
Stenosis 59 59
Angina 46 46
No Patient Involvement 44 44
Myocardial Infarction 42 42
Foreign Body In Patient 38 38
Low Blood Pressure/ Hypotension 33 33
Perforation 29 29
Thrombosis/Thrombus 29 29
Occlusion 26 26
Thrombosis 26 26
Pericardial Effusion 23 23
Insufficient Information 23 23
Cardiac Tamponade 20 20
Intimal Dissection 17 17
Perforation of Vessels 16 16
No Known Impact Or Consequence To Patient 16 16
Injury 15 15
Obstruction/Occlusion 15 15
Hemorrhage/Bleeding 15 15
Cardiogenic Shock 14 14
Ventricular Fibrillation 14 14
No Code Available 14 14
Ischemia 11 11
Pulmonary Edema 10 10
Vascular Dissection 10 10
Non specific EKG/ECG Changes 9 9
Dyspnea 8 8
Device Embedded In Tissue or Plaque 8 8
Restenosis 7 7
Tachycardia 7 7
Cardiac Enzyme Elevation 6 6
Swelling/ Edema 6 6
Extravasation 5 5
Stroke/CVA 5 5
Vessel Or Plaque, Device Embedded In 5 5
Respiratory Distress 5 5
Pain 5 5
Respiratory Failure 5 5
Ventricular Tachycardia 4 4
Bradycardia 4 4
Arrhythmia 4 4
Unspecified Tissue Injury 4 4
Embolism/Embolus 3 3
Pseudoaneurysm 3 3
Chest Pain 3 3
Hematoma 3 3
Vasoconstriction 3 3
Reaction 3 3
Heart Failure 3 3
Low Oxygen Saturation 2 2
Sepsis 2 2
Shock 2 2
Pneumonia 2 2
Embolism 2 2
Atrial Fibrillation 2 2
Inflammation 2 2
Hypersensitivity/Allergic reaction 2 2
High Blood Pressure/ Hypertension 2 2
Nausea 2 2
Hemorrhage, Cerebral 2 2
Diminished Pulse Pressure 2 2
Heart Failure/Congestive Heart Failure 2 2
Unspecified Heart Problem 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Asystole 1 1
Heart Block 1 1
Intracranial Hemorrhage 1 1
Hemothorax 1 1
Hypoxia 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
Mitral Regurgitation 1 1
Pulmonary Embolism 1 1
Calcium Deposits/Calcification 1 1
Embolus 1 1
Hemoptysis 1 1
Fatigue 1 1
Pulmonary Dysfunction 1 1
Rash 1 1
Renal Failure 1 1
Pleural Effusion 1 1
Thrombus 1 1
Blood Loss 1 1
Diaphoresis 1 1
Palpitations 1 1
Myocarditis 1 1
Weakness 1 1
Dizziness 1 1
Hypovolemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Nov-26-2019
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