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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)
2019 2020 2021 2022 2023 2024
5 0 2 1 1 0

MDR Year MDR Reports MDR Events
2019 39 39
2020 25 25
2021 25 25
2022 12 12
2023 7 7
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 79 79
Insufficient Information 32 32
Appropriate Term/Code Not Available 8 8
Off-Label Use 6 6
Material Fragmentation 3 3
Migration 3 3
Use of Device Problem 2 2
Material Separation 2 2
Improper or Incorrect Procedure or Method 2 2
Leak/Splash 1 1
Chemical Problem 1 1
Clumping in Device or Device Ingredient 1 1
Patient-Device Incompatibility 1 1
Unintended Movement 1 1
Patient Device Interaction Problem 1 1
Device Damaged by Another Device 1 1
Material Deformation 1 1
Material Too Soft/Flexible 1 1
Loss of or Failure to Bond 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pseudoaneurysm 30 30
Inflammation 11 11
Death 10 10
Aneurysm 8 8
Unspecified Infection 7 7
Reaction 6 6
Insufficient Information 6 6
Embolism 6 6
No Code Available 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Thromboembolism 5 5
Fistula 5 5
Cerebrospinal Fluid Leakage 5 5
Anaphylactic Shock 4 4
Pain 3 3
Necrosis 3 3
No Information 3 3
Aortic Dissection 3 3
Stroke/CVA 3 3
Swelling/ Edema 2 2
Foreign Body In Patient 2 2
Seroma 2 2
Fever 2 2
Myocardial Infarction 2 2
Neurological Deficit/Dysfunction 2 2
Reaction to Medicinal Component of Device 2 2
Blood Loss 2 2
Obstruction/Occlusion 2 2
Aortic Regurgitation 2 2
Embolism/Embolus 2 2
Ischemia 2 2
Discharge 1 1
Bacterial Infection 1 1
Hypoxia 1 1
Loss of Vision 1 1
Embolus 1 1
Tissue Breakdown 1 1
No Consequences Or Impact To Patient 1 1
Meningitis 1 1
Spinal Cord Injury 1 1
Unspecified Tissue Injury 1 1
Stenosis 1 1
Undesired Nerve Stimulation 1 1
Mitral Regurgitation 1 1
Cancer 1 1
Aortic Valve Insufficiency/ Regurgitation 1 1
Calcium Deposits/Calcification 1 1
Granuloma 1 1
Fluid Discharge 1 1
Urinary Tract Infection 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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