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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device temporary coronary saphenous vein bypass graft for embolic protection
Product CodeNFA
Regulation Number 870.1250
Device Class 2

MDR Year MDR Reports MDR Events
2014 42 42
2015 41 41
2016 63 63
2017 50 50
2018 78 78
2019 40 40
2020 20 20
2021 25 25
2022 23 23
2023 22 22
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 84 84
Detachment of Device or Device Component 66 66
Material Integrity Problem 63 63
Adverse Event Without Identified Device or Use Problem 40 40
Break 39 39
Fracture 22 22
Material Deformation 17 17
Detachment Of Device Component 16 16
Difficult or Delayed Positioning 16 16
Entrapment of Device 16 16
Device Damaged by Another Device 11 11
Retraction Problem 10 10
Leak/Splash 8 8
Burst Container or Vessel 8 8
Failure to Capture 8 8
Inflation Problem 8 8
Deflation Problem 7 7
Kinked 6 6
Positioning Failure 6 6
Use of Device Problem 5 5
Device Damaged Prior to Use 5 5
Difficult to Advance 5 5
Failure to Advance 5 5
Activation, Positioning or Separation Problem 4 4
Device Operates Differently Than Expected 4 4
Torn Material 4 4
Material Separation 4 4
Device Difficult to Setup or Prepare 3 3
Mechanical Problem 3 3
Migration or Expulsion of Device 3 3
Difficult to Fold, Unfold or Collapse 3 3
Device Contamination with Chemical or Other Material 3 3
Sticking 2 2
Defective Device 2 2
Material Distortion 2 2
Physical Resistance/Sticking 2 2
Hole In Material 2 2
Contamination 2 2
Unsealed Device Packaging 2 2
Peeled/Delaminated 2 2
Material Puncture/Hole 2 2
Material Rupture 2 2
Obstruction of Flow 2 2
Structural Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Looping 1 1
Flaked 1 1
Difficult to Insert 1 1
Material Fragmentation 1 1
Device Fell 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Material Twisted/Bent 1 1
No Apparent Adverse Event 1 1
Activation Failure 1 1
Material Split, Cut or Torn 1 1
Patient-Device Incompatibility 1 1
Aspiration Issue 1 1
Blocked Connection 1 1
Contamination /Decontamination Problem 1 1
Component or Accessory Incompatibility 1 1
Physical Resistance 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Device Packaging Compromised 1 1
Device-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 176 177
No Clinical Signs, Symptoms or Conditions 82 82
Patient Problem/Medical Problem 43 43
Device Embedded In Tissue or Plaque 29 29
No Known Impact Or Consequence To Patient 22 22
No Patient Involvement 16 16
Embolism 16 16
Death 8 8
Foreign Body In Patient 8 8
Vascular Dissection 7 7
Stroke/CVA 5 5
Hematoma 5 5
Occlusion 5 5
Perforation 5 5
Thrombus 5 5
Stenosis 4 4
Intimal Dissection 4 4
Reocclusion 3 3
Obstruction/Occlusion 3 3
Low Blood Pressure/ Hypotension 3 3
Myocardial Infarction 3 3
Insufficient Information 3 3
No Information 2 2
Paresis 2 2
Transient Ischemic Attack 2 2
Vasoconstriction 2 2
ST Segment Elevation 2 2
Injury 2 2
Vessel Or Plaque, Device Embedded In 2 2
Infarction, Cerebral 1 1
Chest Pain 1 1
Aneurysm 1 1
Atherosclerosis 1 1
Bradycardia 1 1
Cardiac Arrest 1 1
Pain 1 1
Paralysis 1 1
Hemorrhage/Bleeding 1 1
Hemorrhage, Cerebral 1 1
Embolus 1 1
Coma 1 1
Thrombosis 1 1
Chemical Exposure 1 1
Pseudoaneurysm 1 1
Perforation of Vessels 1 1
Inflammation 1 1
No Code Available 1 1
Embolism/Embolus 1 1

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