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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
Regulation Description Percutaneous catheter.
Product CodeNFA
Regulation Number 870.1250
Device Class 2

MDR Year MDR Reports MDR Events
2020 20 20
2021 25 25
2022 23 23
2023 22 22
2024 55 55
2025 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 85 85
Difficult to Remove 61 61
Adverse Event Without Identified Device or Use Problem 22 22
Difficult or Delayed Positioning 22 22
Difficult to Advance 11 11
Break 6 6
Entrapment of Device 5 5
Failure to Advance 4 4
Mechanical Problem 3 3
Device Difficult to Setup or Prepare 3 3
Detachment of Device or Device Component 3 3
Fracture 3 3
Activation, Positioning or Separation Problem 2 2
Device-Device Incompatibility 2 2
Defective Device 2 2
Retraction Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Material Split, Cut or Torn 1 1
Migration or Expulsion of Device 1 1
Device Markings/Labelling Problem 1 1
Unsealed Device Packaging 1 1
Contamination 1 1
Device Damaged by Another Device 1 1
Material Separation 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 143 143
No Consequences Or Impact To Patient 17 17
Foreign Body In Patient 4 4
Vasoconstriction 3 3
Insufficient Information 3 3
Obstruction/Occlusion 2 2
Stenosis 2 2
Device Embedded In Tissue or Plaque 2 2
High Blood Pressure/ Hypertension 1 1
Vascular Dissection 1 1
Perforation 1 1
Embolism/Embolus 1 1
Cardiac Arrest 1 1
No Known Impact Or Consequence To Patient 1 1
Paralysis 1 1
Coma 1 1
Myocardial Infarction 1 1

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