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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, anastomotic, microvascular
Regulation Description Implantable clip.
Product CodeMVR
Regulation Number 878.4300
Device Class 2

MDR Year MDR Reports MDR Events
2020 43 43
2021 35 35
2022 18 22
2023 28 28
2024 38 38
2025 90 90

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 54 54
Disconnection 39 39
Material Twisted/Bent 37 37
Detachment of Device or Device Component 32 32
Difficult to Open or Close 27 27
Device Dislodged or Dislocated 15 15
Incomplete or Inadequate Connection 10 10
Break 8 8
Loose or Intermittent Connection 8 8
Fitting Problem 5 5
Misconnection 5 5
Defective Component 3 3
Failure to Align 3 7
Material Deformation 3 3
Component Missing 2 2
Failure to Disconnect 2 2
Entrapment of Device 1 1
Physical Resistance/Sticking 1 1
Device Alarm System 1 1
Crack 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Failure to Sense 1 1
Obstruction of Flow 1 1
Product Quality Problem 1 1
Fracture 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 152 156
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
No Consequences Or Impact To Patient 27 27
Injury 12 12
Thrombosis/Thrombus 10 10
No Patient Involvement 8 8
Perforation of Vessels 6 6
Insufficient Information 3 3
Stenosis 3 3
Thrombus 3 3
Failure to Anastomose 2 2
Foreign Body Sensation in Eye 1 1
Unspecified Infection 1 1
Failure of Implant 1 1
Discomfort 1 1
Hemorrhage/Bleeding 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jan-30-2021
2 Baxter Healthcare Corporation II Jun-30-2020
3 Baxter Healthcare Corporation II Apr-08-2020
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