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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device sizer, heart-valve, prosthesis
Regulation Description Prosthetic heart valve sizer.
Product CodeDTI
Regulation Number 870.3945
Device Class 1

MDR Year MDR Reports MDR Events
2015 5 5
2016 7 7
2017 1 1
2018 1 1
2019 1 1
2020 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 8 8
Fracture 7 7
Material Fragmentation 2 2
Migration or Expulsion of Device 1 1
Component Missing 1 1
Detachment of Device or Device Component 1 1
Appropriate Term/Code Not Available 1 1
Crack 1 1
Perivalvular Leak 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 7 7
No Known Impact Or Consequence To Patient 5 6
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Congestive Heart Failure 1 1
Dyspnea 1 1
Endocarditis 1 1
Infiltration into Tissue 1 1
No Consequences Or Impact To Patient 1 1
Injury 1 1
Foreign Body In Patient 1 1

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