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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ring, annuloplasty
Regulation Description Annuloplasty ring.
Product CodeKRH
Regulation Number 870.3800
Device Class 2


Premarket Reviews
ManufacturerDecision
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
GENESEE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Insufficient Information 1033
Adverse Event Without Identified Device or Use Problem 418
Inadequacy of Device Shape and/or Size 91
Device Operates Differently Than Expected 50
Appropriate Term/Code Not Available 46
Gradient Increase 26
Patient-Device Incompatibility 23
Incomplete Coaptation 22
Perivalvular Leak 21
No Apparent Adverse Event 17
Material Separation 16
Backflow 13
Calcified 9
Leak/Splash 8
Detachment of Device or Device Component 7
Off-Label Use 7
Obstruction of Flow 6
Material Deformation 6
Device Dislodged or Dislocated 5
Material Integrity Problem 5
Improper or Incorrect Procedure or Method 5
Degraded 4
Malposition of Device 3
Biocompatibility 3
Fracture 3
Occlusion Within Device 3
Improper Flow or Infusion 2
Device Appears to Trigger Rejection 2
Use of Device Problem 2
Unintended Movement 2
Material Distortion 2
Material Split, Cut or Torn 2
Separation Problem 2
Structural Problem 2
Material Fragmentation 1
Device Damaged Prior to Use 1
Material Frayed 1
Human-Device Interface Problem 1
Expiration Date Error 1
Reflux within Device 1
Separation Failure 1
Break 1
Material Twisted/Bent 1
Incorrect, Inadequate or Imprecise Resultor Readings 1
Patient Device Interaction Problem 1
Bent 1
Device Contamination With Biological Material 1
Split 1
Migration or Expulsion of Device 1
Torn Material 1
Deformation Due to Compressive Stress 1
Material Rupture 1
Detachment Of Device Component 1
Crack 1
Total Device Problems 1886


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