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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sizer, heart-valve, prosthesis
Product CodeDTI
Regulation Number 870.3945
Device Class 1

MDR Year MDR Reports MDR Events
2014 6 6
2015 5 5
2016 7 7
2017 1 1
2018 1 1
2019 1 1
2020 1 1
2021 4 4
2022 2 2
2023 27 27
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 27 27
Fracture 12 12
Break 9 9
Component Missing 2 2
Material Fragmentation 2 2
Crack 2 2
Patient Device Interaction Problem 2 2
Degraded 1 1
Material Discolored 1 1
Fluid/Blood Leak 1 1
Migration or Expulsion of Device 1 1
Perivalvular Leak 1 1
Fitting Problem 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Scratched Material 1 1
Detachment Of Device Component 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 11 11
No Information 9 9
Heart Block 8 8
No Known Impact Or Consequence To Patient 7 8
No Clinical Signs, Symptoms or Conditions 7 7
No Consequences Or Impact To Patient 3 3
Aortic Valve Insufficiency/ Regurgitation 2 2
Arrhythmia 2 2
Hemorrhage/Bleeding 2 2
Infiltration into Tissue 1 1
Myocardial Infarction 1 1
Tachycardia 1 1
Atrial Fibrillation 1 1
Stroke/CVA 1 1
Congestive Heart Failure 1 1
Dyspnea 1 1
Endocarditis 1 1
Hematoma 1 1
Mitral Valve Insufficiency/ Regurgitation 1 1
Unspecified Tissue Injury 1 1
Injury 1 1
Foreign Body In Patient 1 1
Vascular Dissection 1 1
Pericardial Effusion 1 1
Syncope/Fainting 1 1
Aortic Valve Stenosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic CoreValve LLC II Feb-14-2020
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