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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)
2017 2018 2019 2020 2021 2022
35 32 25 21 13 8

MDR Year MDR Reports MDR Events
2017 694 694
2018 667 667
2019 561 561
2020 429 429
2021 329 329
2022 245 245

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Advance 1049 1049
Adverse Event Without Identified Device or Use Problem 496 496
Improper or Incorrect Procedure or Method 352 352
Device Dislodged or Dislocated 323 323
Material Deformation 295 295
Patient-Device Incompatibility 255 255
Device Operates Differently Than Expected 166 166
Difficult to Remove 137 137
Material Separation 108 108
Off-Label Use 98 98
Difficult to Advance 90 90
Bent 84 84
Break 59 59
Deformation Due to Compressive Stress 55 55
Detachment Of Device Component 54 54
Difficult To Position 30 30
Inflation Problem 29 29
Material Rupture 27 27
Fracture 26 26
Activation Failure 26 26
Kinked 25 25
Positioning Failure 24 24
Device Expiration Issue 24 24
Device Damaged Prior to Use 24 24
Migration 22 22
Physical Resistance 21 21
Device Damaged by Another Device 19 19
Difficult or Delayed Positioning 19 19
Deflation Problem 16 16
Difficult or Delayed Activation 16 16
Detachment of Device or Device Component 15 15
Unstable 15 15
Activation, Positioning or Separation Problem 14 14
Defective Device 14 14
Leak/Splash 13 13
Occlusion Within Device 13 13
Insufficient Information 12 12
Material Split, Cut or Torn 10 10
Entrapment of Device 10 10
Migration or Expulsion of Device 9 9
Difficult to Insert 9 9
Malposition of Device 9 9
No Apparent Adverse Event 9 9
Material Twisted/Bent 9 9
Use of Device Problem 8 8
Mechanical Problem 8 8
Premature Activation 7 7
Burst Container or Vessel 6 6
Component Missing 6 6
Positioning Problem 6 6
Torn Material 5 5
Unintended Movement 5 5
Product Quality Problem 5 5
Therapy Delivered to Incorrect Body Area 5 5
Retraction Problem 4 4
Fluid/Blood Leak 4 4
Device-Device Incompatibility 4 4
Material Integrity Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Physical Property Issue 3 3
Unintended System Motion 3 3
Unsealed Device Packaging 3 3
Failure to Deliver 3 3
Device Issue 3 3
Stretched 3 3
Device Packaging Compromised 2 2
Peeled/Delaminated 2 2
Failure to Fold 2 2
Incorrect Measurement 1 1
Material Puncture/Hole 1 1
Flushing Problem 1 1
Filling Problem 1 1
Failure to Capture 1 1
Collapse 1 1
Contamination 1 1
Partial Blockage 1 1
Loss of or Failure to Bond 1 1
Device Sensing Problem 1 1
Device Markings/Labelling Problem 1 1
Contamination /Decontamination Problem 1 1
Defective Component 1 1
Dent in Material 1 1
Unraveled Material 1 1
Malfunction 1 1
Obstruction of Flow 1 1
Material Too Rigid or Stiff 1 1
Self-Activation or Keying 1 1
Device Slipped 1 1
Sticking 1 1
Moisture or Humidity Problem 1 1
Power Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Expulsion 1 1
Material Too Soft/Flexible 1 1
Firing Problem 1 1
Failure to Deflate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1421 1422
No Clinical Signs, Symptoms or Conditions 436 436
Death 249 249
Cardiac Arrest 133 133
No Patient Involvement 115 115
Stenosis 108 108
Myocardial Infarction 107 107
Angina 89 89
Thrombosis 82 82
Occlusion 77 77
Foreign Body In Patient 65 65
No Known Impact Or Consequence To Patient 58 58
Perforation 47 47
Low Blood Pressure/ Hypotension 46 46
Cardiac Tamponade 44 44
Intimal Dissection 36 36
Patient Problem/Medical Problem 35 35
Cardiogenic Shock 30 30
Ischemia 29 29
Hemorrhage/Bleeding 26 26
Pericardial Effusion 26 26
Dyspnea 25 25
Ventricular Fibrillation 24 24
Thrombosis/Thrombus 22 22
Insufficient Information 21 21
No Code Available 20 20
Reocclusion 19 19
Vessel Or Plaque, Device Embedded In 19 19
Cardiac Enzyme Elevation 16 16
Injury 16 16
Vascular Dissection 15 15
Device Embedded In Tissue or Plaque 13 13
Reaction 13 13
Heart Failure 13 13
Chest Pain 13 13
Non specific EKG/ECG Changes 13 13
Pain 13 13
Ventricular Tachycardia 13 13
Vasoconstriction 13 13
Stroke/CVA 12 12
Bradycardia 11 11
Thrombus 11 11
Pulmonary Edema 10 10
Perforation of Vessels 10 10
Respiratory Failure 10 10
Obstruction/Occlusion 9 9
Nausea 9 9
Shock 8 8
Tachycardia 8 8
Respiratory Distress 7 7
Hypersensitivity/Allergic reaction 7 7
Test Result 7 7
Restenosis 7 7
Pseudoaneurysm 6 6
High Blood Pressure/ Hypertension 6 6
Embolism 6 6
Extravasation 5 5
Arrhythmia 5 5
Sepsis 5 5
Dizziness 5 5
Urticaria 4 4
Swelling/ Edema 4 4
Unspecified Tissue Injury 4 4
Pulmonary Dysfunction 4 4
Renal Failure 4 4
Skin Irritation 4 4
Aneurysm 4 4
Atrial Fibrillation 3 3
Fistula 3 3
Hemorrhage, Cerebral 3 3
Unspecified Infection 3 3
Diaphoresis 3 3
Sudden Cardiac Death 3 3
Blood Loss 3 3
No Information 2 2
Diminished Pulse Pressure 2 2
Heart Failure/Congestive Heart Failure 2 2
Failure of Implant 2 2
Pneumonia 2 2
Swelling 2 2
ST Segment Elevation 2 2
Intracranial Hemorrhage 2 2
Hematoma 2 2
Fatigue 2 2
Pulmonary Embolism 2 2
Anemia 2 2
Calcium Deposits/Calcification 2 2
Edema 1 1
Atrial Tachycardia 1 1
Fever 1 1
Embolus 1 1
Endocarditis 1 1
Congenital Defect/Deformity 1 1
Hemoptysis 1 1
Hemorrhage, Subarachnoid 1 1
Hemorrhage, Subdural 1 1
Hemothorax 1 1
Right Ventricular Failure 1 1
Rash 1 1
Transient Ischemic Attack 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Nov-26-2019
2 Cordis Corporation II Apr-15-2017
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