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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
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
Material Integrity Problem 61 61
Difficult to Remove 36 36
Difficult or Delayed Positioning 15 15
Break 13 13
Detachment of Device or Device Component 12 12
Fracture 8 8
Entrapment of Device 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Difficult to Advance 5 5
Failure to Advance 3 3
Mechanical Problem 3 3
Retraction Problem 2 2
Material Separation 2 2
Device Difficult to Setup or Prepare 2 2
Defective Device 2 2
Device Contamination with Chemical or Other Material 2 2
Material Deformation 2 2
Activation, Positioning or Separation Problem 2 2
Contamination /Decontamination Problem 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Activation Failure 1 1
Material Split, Cut or Torn 1 1
Material Puncture/Hole 1 1
Device Markings/Labelling Problem 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Migration or Expulsion of Device 1 1
Unsealed Device Packaging 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 82 82
No Consequences Or Impact To Patient 35 35
Patient Problem/Medical Problem 8 8
Device Embedded In Tissue or Plaque 7 7
No Patient Involvement 6 6
Foreign Body In Patient 3 3
Insufficient Information 3 3
Vascular Dissection 2 2
Embolism 2 2
Perforation 2 2
Transient Ischemic Attack 1 1
Vasoconstriction 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1
Hematoma 1 1
Myocardial Infarction 1 1
Reocclusion 1 1
Paralysis 1 1
No Known Impact Or Consequence To Patient 1 1
Stenosis 1 1
Injury 1 1
Coma 1 1
Obstruction/Occlusion 1 1
Embolism/Embolus 1 1

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