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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
BAXTER HEALTHCARE CORP.
  SE - POSTMARKET SURVEILLANCE REQUIRED 2
  SUBSTANTIALLY EQUIVALENT 3
CARBOMEDICS, INC.
  1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 6
GENESEE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8
MEDICALCV, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  1
  SUBSTANTIALLY EQUIVALENT 10
MICARDIA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PETERS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
SHELHIGH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 2
SORIN
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL, INC.
  1
  SUBSTANTIALLY EQUIVALENT 9
SULZER
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Unknown (for use when the device problem is not known) 2615
Paravalvular leak 440
No Known Device Problem 313
No Information 246
Deterioration of prosthesis 80
Size incorrect for patient 60
Perivalvular leak 56
Other (for use when an appropriate device code cannot be identified) 48
Device operates differently than expected 44
No code available 41
Incomplete coaptation 19
Gradient increase 13
Explanted 13
Calcified 10
Fracture 7
Leak 7
Performance 5
Patient-device incompatibility 5
Material separation 4
Material deformation 4
Human-Device Interface Issue 3
Material integrity issue 3
Structural problem 3
Detachment of device component 3
Degraded 3
Difficult to deploy 3
Device remains implanted 2
Replace 2
Tears, rips, holes in device, device material 2
Improper or incorrect procedure or method 1
Device damaged prior to use 1
Blood pooling 1
Cut in material 1
Detachment of device or device component 1
Split 1
Failure to separate 1
Fibrosis 1
Malposition of device 1
Material rupture 1
User used incorrect product for intended use 1
Bent 1
Break 1
Material fragmentation 1
Material frayed 1
Dislodged or dislocated 1
Material Distortion 1
Torn material 1
Total Device Problems 4072

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