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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coronary mechanical thrombectomy with aspiration
Regulation Description Embolectomy catheter.
Definition To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.
Product CodeQEX
Regulation Number 870.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
VESALIO, INC.
  SE - WITH LIMITATIONS 1

MDR Year MDR Reports MDR Events
2021 81 81
2022 16 17
2023 25 25
2024 25 25
2025 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 69 70
Break 59 60
Fracture 57 57
Material Deformation 40 41
Failure to Advance 14 14
Suction Failure 6 6
Material Puncture/Hole 6 6
Connection Problem 2 2
Leak/Splash 1 1
Positioning Problem 1 1
Stretched 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Migration 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 160 161
No Consequences Or Impact To Patient 14 14
Foreign Body In Patient 10 10
Laceration(s) 2 2
Device Embedded In Tissue or Plaque 2 2
Stroke/CVA 1 1
Insufficient Information 1 1

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