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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 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 71 71
Difficult to Remove 44 44
Difficult or Delayed Positioning 17 17
Break 13 13
Detachment of Device or Device Component 12 12
Adverse Event Without Identified Device or Use Problem 9 9
Entrapment of Device 8 8
Fracture 8 8
Difficult to Advance 6 6
Mechanical Problem 3 3
Device Difficult to Setup or Prepare 3 3
Failure to Advance 3 3
Device-Device Incompatibility 2 2
Activation, Positioning or Separation Problem 2 2
Defective Device 2 2
Material Deformation 2 2
Device Contamination with Chemical or Other Material 2 2
Material Separation 2 2
Retraction Problem 2 2
Migration or Expulsion of Device 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1
Device Damaged by Another Device 1 1
Material Split, Cut or Torn 1 1
Device Markings/Labelling Problem 1 1
Material Puncture/Hole 1 1
Positioning Problem 1 1
Unsealed Device Packaging 1 1
Packaging Problem 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 100 100
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
Vasoconstriction 3 3
Foreign Body In Patient 3 3
Insufficient Information 3 3
Vascular Dissection 2 2
Perforation 2 2
Embolism 2 2
Stroke/CVA 1 1
Hematoma 1 1
Embolism/Embolus 1 1
Obstruction/Occlusion 1 1
Transient Ischemic Attack 1 1
Cardiac Arrest 1 1
No Known Impact Or Consequence To Patient 1 1
Injury 1 1
Paralysis 1 1
Coma 1 1
Reocclusion 1 1
Stenosis 1 1
Myocardial Infarction 1 1

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