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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
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CORCYM S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 2
GENESEE BIOMEDICAL INC
  SUBSTANTIALLY EQUIVALENT 3
GENESEE BIOMEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 340 340
2021 423 423
2022 372 372
2023 324 324
2024 407 407
2025 350 350

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1244 1244
Adverse Event Without Identified Device or Use Problem 523 523
Patient Device Interaction Problem 296 296
Central Regurgitation 157 157
Inadequacy of Device Shape and/or Size 93 93
Lack of Effect 38 38
Material Separation 36 36
Appropriate Term/Code Not Available 34 34
Backflow 28 28
Gradient Increase 23 23
Device Stenosis 23 23
Fluid/Blood Leak 21 21
Detachment of Device or Device Component 18 18
Perivalvular Leak 16 16
Leak/Splash 14 14
Break 12 12
Incomplete Coaptation 12 12
Patient-Device Incompatibility 9 9
Material Split, Cut or Torn 7 7
Calcified 7 7
Improper or Incorrect Procedure or Method 6 6
No Apparent Adverse Event 5 5
Material Deformation 5 5
Degraded 5 5
Reflux within Device 4 4
Fracture 4 4
Tear, Rip or Hole in Device Packaging 4 4
Partial Blockage 4 4
Packaging Problem 4 4
Obstruction of Flow 4 4
Thickening of Material 3 3
Material Protrusion/Extrusion 3 3
Delivered as Unsterile Product 3 3
Structural Problem 3 3
Improper Flow or Infusion 3 3
Use of Device Problem 3 3
Material Integrity Problem 2 2
Unsealed Device Packaging 2 2
Unintended Movement 2 2
Device Markings/Labelling Problem 2 2
Device Dislodged or Dislocated 2 2
Difficult to Open or Remove Packaging Material 2 2
Material Frayed 2 2
Biocompatibility 2 2
Contamination /Decontamination Problem 1 1
Difficult to Remove 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Device 1 1
Expiration Date Error 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1105 1105
Mitral Valve Insufficiency/ Regurgitation 397 397
No Information 190 190
Non specific EKG/ECG Changes 153 153
Atrial Fibrillation 131 131
Mitral Regurgitation 121 121
Heart Block 101 101
Tricuspid Valve Insufficiency/ Regurgitation 77 77
No Clinical Signs, Symptoms or Conditions 75 75
Mitral Valve Stenosis 75 75
Stroke/CVA 73 73
Hemorrhage/Bleeding 53 53
Endocarditis 48 48
Dyspnea 46 46
Tachycardia 46 46
Heart Failure/Congestive Heart Failure 42 42
Bradycardia 32 32
Cardiomyopathy 31 31
Pericardial Effusion 31 31
Pleural Effusion 28 28
Atrial Flutter 24 24
Unspecified Infection 19 19
Myocardial Infarction 19 19
Tricuspid Regurgitation 19 19
Low Cardiac Output 18 18
Blood Loss 16 16
Anemia 16 16
Transient Ischemic Attack 15 15
Arrhythmia 15 15
Pneumothorax 15 15
Valvular Insufficiency/ Regurgitation 14 14
Aortic Valve Insufficiency/ Regurgitation 13 13
Coagulation Disorder 13 13
Hematoma 13 13
Renal Failure 12 12
Hemothorax 11 11
Respiratory Failure 10 10
Cardiac Arrest 10 10
Thromboembolism 9 9
Chest Pain 9 9
Thrombosis/Thrombus 9 9
Post Operative Wound Infection 9 9
Cusp Tear 9 9
Hemolysis 8 8
No Known Impact Or Consequence To Patient 8 8
Congestive Heart Failure 8 8
Sepsis 7 7
Ventricular Fibrillation 7 7
Tricuspid Valve Stenosis 7 7
Death 7 7

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