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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device scaffold, dissection repair
Definition For the repair of dissections following percutaneous transluminal angioplasty in the lower extremity arteries
Product CodeQCT
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 0 1 5 3 5 0 0

MDR Year MDR Reports MDR Events
2019 1 1
2020 3 3
2021 6 6
2022 2 2
2023 1 1
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Failure 9 9
Entrapment of Device 6 6
Unintended Collision 4 4
Ejection Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Device Damaged by Another Device 3 3
Material Separation 2 2
Device Dislodged or Dislocated 2 2
Insufficient Information 1 1
Unintended Movement 1 1
Positioning Problem 1 1
Off-Label Use 1 1
Retraction Problem 1 1
Migration 1 1
Inadequacy of Device Shape and/or Size 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
Thrombus 2 2
Failure of Implant 1 1
Obstruction/Occlusion 1 1
Foreign Body In Patient 1 1
Discomfort 1 1
Pain 1 1

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