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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
36 55 67 77 41 54 22 26 35 32 25 21 13 8 8 2

MDR Year MDR Reports MDR Events
2014 875 875
2015 662 662
2016 696 696
2017 694 694
2018 675 675
2019 561 561
2020 429 429
2021 329 329
2022 280 280
2023 208 208
2024 82 82

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Advance 1846 1846
Adverse Event Without Identified Device or Use Problem 806 806
Improper or Incorrect Procedure or Method 684 684
Device Dislodged or Dislocated 661 661
Material Deformation 442 442
Bent 340 340
Difficult to Remove 312 312
Patient-Device Incompatibility 290 290
Device Operates Differently Than Expected 254 254
Leak/Splash 216 216
Detachment Of Device Component 177 177
Break 165 165
Material Separation 140 140
Difficult to Advance 122 122
Off-Label Use 103 103
Occlusion Within Device 93 93
Device Damaged Prior to Use 90 90
Difficult To Position 89 89
Kinked 73 73
Difficult or Delayed Positioning 73 73
Device Expiration Issue 69 69
Material Rupture 67 67
Deformation Due to Compressive Stress 66 66
Physical Resistance 60 60
Inflation Problem 59 59
Fracture 52 52
Positioning Failure 45 45
Activation, Positioning or Separation Problem 45 45
Device Damaged by Another Device 44 44
Deflation Problem 37 37
Unstable 36 36
Activation Failure 35 35
Migration or Expulsion of Device 33 33
Detachment of Device or Device Component 26 26
Insufficient Information 25 25
Migration 23 23
Entrapment of Device 21 21
Defective Device 19 19
Difficult or Delayed Activation 16 16
Device Contamination with Chemical or Other Material 16 16
Material Twisted/Bent 15 15
Material Split, Cut or Torn 15 15
Malposition of Device 14 14
Difficult to Insert 14 14
Component Missing 13 13
No Apparent Adverse Event 12 12
Torn Material 11 11
Positioning Problem 11 11
Mechanical Problem 11 11
Premature Activation 10 10
Use of Device Problem 9 9
Burst Container or Vessel 9 9
Product Quality Problem 6 6
Therapy Delivered to Incorrect Body Area 6 6
Retraction Problem 6 6
Stretched 6 6
Unintended Movement 6 6
Material Integrity Problem 5 5
Device Slipped 5 5
Failure to Deliver 5 5
Fluid/Blood Leak 5 5
Unsealed Device Packaging 4 4
Peeled/Delaminated 4 4
Device Markings/Labelling Problem 4 4
Device-Device Incompatibility 4 4
Device Packaging Compromised 3 3
Physical Property Issue 3 3
Device Issue 3 3
Material Fragmentation 3 3
Unintended System Motion 3 3
Crack 3 3
Partial Blockage 2 2
Failure To Adhere Or Bond 2 2
Collapse 2 2
Failure to Fold 2 2
Device Or Device Fragments Location Unknown 2 2
Material Puncture/Hole 2 2
Sticking 2 2
Unraveled Material 2 2
Self-Activation or Keying 2 2
Expulsion 2 2
Component or Accessory Incompatibility 2 2
Device Sensing Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Folded 1 1
Contamination /Decontamination Problem 1 1
Failure To Unwrap 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Moisture or Humidity Problem 1 1
No Fail-Safe Mechanism 1 1
Material Distortion 1 1
Power Problem 1 1
Firing Problem 1 1
Physical Resistance/Sticking 1 1
Failure to Deflate 1 1
Wrong Label 1 1
Material Too Soft/Flexible 1 1
Material Too Rigid or Stiff 1 1
Dent in Material 1 1
Increased Sensitivity 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2705 2706
No Clinical Signs, Symptoms or Conditions 724 724
Death 442 442
No Patient Involvement 312 312
Cardiac Arrest 200 201
Myocardial Infarction 188 188
Thrombosis 179 179
Angina 162 162
Stenosis 156 156
Foreign Body In Patient 113 113
Occlusion 112 112
Low Blood Pressure/ Hypotension 92 92
No Known Impact Or Consequence To Patient 91 91
Perforation 89 89
Cardiac Tamponade 81 81
Intimal Dissection 75 75
Reocclusion 71 71
Cardiogenic Shock 70 70
Patient Problem/Medical Problem 57 57
Hemorrhage/Bleeding 53 53
Ischemia 49 49
Ventricular Fibrillation 46 46
Respiratory Failure 36 37
No Code Available 36 36
Dyspnea 36 36
Chest Pain 36 36
Non specific EKG/ECG Changes 35 35
Device Embedded In Tissue or Plaque 35 35
Bradycardia 33 33
Vessel Or Plaque, Device Embedded In 31 31
Cardiac Enzyme Elevation 31 31
Thrombosis/Thrombus 31 31
Pericardial Effusion 30 30
Reaction 26 26
Insufficient Information 25 25
Pain 25 25
Thrombus 24 24
Ventricular Tachycardia 22 22
Vasoconstriction 22 22
Stroke/CVA 20 20
Hypersensitivity/Allergic reaction 19 19
Obstruction/Occlusion 19 19
Vascular Dissection 19 19
Test Result 17 17
Perforation of Vessels 17 17
Injury 16 16
Heart Failure 16 16
No Information 15 15
Respiratory Distress 14 14
Aneurysm 13 13
Arrhythmia 13 13
Pulmonary Edema 12 12
Embolism 11 11
Nausea 10 10
ST Segment Elevation 9 9
High Blood Pressure/ Hypertension 9 9
Tachycardia 9 9
Shock 9 9
Pseudoaneurysm 8 8
Sepsis 8 8
Atrial Fibrillation 7 7
Restenosis 7 7
Swelling 7 7
Dizziness 7 7
Renal Failure 6 6
Swelling/ Edema 6 6
Blood Loss 6 6
Anemia 6 6
Extravasation 5 5
Headache 5 5
Unspecified Infection 5 5
Pulmonary Dysfunction 4 4
Unspecified Tissue Injury 4 4
Skin Irritation 4 4
Urticaria 4 4
Diaphoresis 4 4
Transient Ischemic Attack 3 3
Weakness 3 3
Embolism/Embolus 3 3
Sudden Cardiac Death 3 3
Neurological Deficit/Dysfunction 3 3
Inflammation 3 3
Left Ventricular Hypertrophy 3 3
Hematoma 3 3
Hemorrhage, Cerebral 3 3
Fatigue 3 3
Calcium Deposits/Calcification 3 3
Fistula 3 3
Infarction, Cerebral 3 3
Pulmonary Embolism 3 3
Syncope 2 2
Atrial Tachycardia 2 2
Disseminated Intravascular Coagulation (DIC) 2 2
Fever 2 2
Intracranial Hemorrhage 2 2
Failure of Implant 2 2
Neonatal Deformities 2 2
Pneumonia 2 2
Rash 2 2
Low Oxygen Saturation 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular-Cardiac Therapies dba Guidant Corporation I Jul-29-2009
2 Abbott Vascular-Cardiac Therapies dba Guidant Corporation II Feb-03-2009
3 Boston Scientific Corporation II Nov-26-2019
4 Boston Scientific Corporation II Oct-21-2009
5 Cordis Corporation II Apr-15-2017
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