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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)
2020 2021 2022 2023 2024 2025
5 3 5 0 0 0

MDR Year MDR Reports MDR Events
2020 3 3
2021 6 6
2022 2 2
2023 1 1
2024 464 464

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 160 160
Ejection Problem 156 156
Positioning Failure 107 107
Failure to Unfold or Unwrap 14 14
Unintended Ejection 12 12
Entrapment of Device 6 6
Malposition of Device 6 6
Improper or Incorrect Procedure or Method 4 4
Unintended Collision 4 4
Device Damaged by Another Device 3 3
Material Separation 2 2
Migration 2 2
Device Dislodged or Dislocated 2 2
Off-Label Use 1 1
Insufficient Information 1 1
Positioning Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Retraction Problem 1 1
Inadequacy of Device Shape and/or Size 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 469 469
Foreign Body In Patient 2 2
Thrombus 2 2
Failure of Implant 1 1
Obstruction/Occlusion 1 1
Insufficient Information 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Spectranetics Corporation I Feb-14-2025
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