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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device glue, surgical, arteries
Product CodeMUQ
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
2 1 1 0 1 0

MDR Year MDR Reports MDR Events
2021 25 25
2022 12 12
2023 7 7
2024 14 14
2025 11 11
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 53 53
Insufficient Information 10 10
Material Fragmentation 4 4
Patient-Device Incompatibility 2 2
Appropriate Term/Code Not Available 2 2
Material Separation 2 2
Chemical Problem 1 1
Device Damaged by Another Device 1 1
Material Deformation 1 1
Unintended Movement 1 1
Patient Device Interaction Problem 1 1
Material Too Soft/Flexible 1 1
Off-Label Use 1 1
Clumping in Device or Device Ingredient 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pseudoaneurysm 20 20
Inflammation 10 10
Insufficient Information 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Cerebrospinal Fluid Leakage 5 5
Aneurysm 5 5
Thromboembolism 4 4
Anaphylactic Shock 4 4
Unspecified Infection 3 3
Death 3 3
Embolism/Embolus 3 3
Stroke/CVA 2 2
Hypersensitivity/Allergic reaction 2 2
Spinal Cord Injury 2 2
Hemorrhage/Bleeding 2 2
Reaction to Medicinal Component of Device 2 2
Obstruction/Occlusion 2 2
Coma 2 2
Swelling/ Edema 2 2
Respiratory Failure 1 1
Quadriplegia 1 1
Tissue Breakdown 1 1
Granuloma 1 1
Cancer 1 1
Aortic Valve Insufficiency/ Regurgitation 1 1
Myocardial Infarction 1 1
Embolism 1 1
Unspecified Tissue Injury 1 1
Stenosis 1 1
Fluid Discharge 1 1
Pneumonia 1 1
Pain 1 1
Valvular Stenosis 1 1
Chest Pain 1 1
Erythema 1 1
Foreign Body Embolism 1 1
Ventricular Fibrillation 1 1
Thrombosis/Thrombus 1 1
Transient Ischemic Attack 1 1
Low Cardiac Output 1 1
Itching Sensation 1 1
Muscle Weakness 1 1
Necrosis 1 1
No Code Available 1 1
Wound Dehiscence 1 1
Speech Disorder 1 1
Solid Tumour 1 1
Urticaria 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CryoLife, Inc. II Dec-15-2021
2 Siemens Medical Solutions USA, Inc II Nov-16-2021
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