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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


Premarket Reviews
ManufacturerDecision
BAXTER/ SYNOVIS MICRO COMPANIES ALLIANCE INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 22 22
2017 13 13
2018 13 13
2019 44 50
2020 43 43
2021 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 37 37
Adverse Event Without Identified Device or Use Problem 25 25
Disconnection 23 29
Material Twisted/Bent 20 20
Break 8 8
Detachment of Device or Device Component 7 7
Device Dislodged or Dislocated 5 5
Fitting Problem 5 5
Loose or Intermittent Connection 4 4
Difficult to Open or Close 4 4
Misconnection 3 3
Connection Problem 3 3
Material Deformation 3 3
Incomplete or Inadequate Connection 2 2
Defective Component 2 2
Failure to Disconnect 2 2
Crack 2 2
Obstruction of Flow 2 2
Fluid Leak 2 2
Failure to Sense 1 1
Device Slipped 1 1
Component Missing 1 1
Bent 1 1
Unintended Ejection 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Fire 1 1
Material Rupture 1 1
Improper or Incorrect Procedure or Method 1 1
Device Alarm System 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 55 61
No Known Impact Or Consequence To Patient 41 41
Injury 20 20
No Patient Involvement 17 17
No Clinical Signs, Symptoms or Conditions 13 13
Perforation of Vessels 4 4
Thrombus 3 3
Insufficient Information 2 2
Complaint, Ill-Defined 2 2
No Information 2 2
Device Embedded In Tissue or Plaque 1 1
Blood Loss 1 1
Intimal Dissection 1 1
Foreign Body Sensation in Eye 1 1
Tissue Damage 1 1
Discomfort 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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