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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 4
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 340 340
2021 423 423
2022 372 373
2023 324 326
2024 407 408
2025 425 425
2026 36 36

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1270 1272
Adverse Event Without Identified Device or Use Problem 566 568
Patient Device Interaction Problem 327 327
Central Regurgitation 174 174
Inadequacy of Device Shape and/or Size 93 93
Lack of Effect 44 44
Material Separation 37 37
Appropriate Term/Code Not Available 36 36
Backflow 28 28
Device Stenosis 25 25
Gradient Increase 23 24
Fluid/Blood Leak 21 22
Detachment of Device or Device Component 18 18
Perivalvular Leak 17 17
Break 16 16
Leak/Splash 15 15
Incomplete Coaptation 14 14
Patient-Device Incompatibility 9 9
Calcified 8 8
Material Split, Cut or Torn 8 8
Improper or Incorrect Procedure or Method 6 6
Degraded 5 5
Material Deformation 5 5
No Apparent Adverse Event 5 5
Structural Problem 5 5
Fracture 4 4
Reflux within Device 4 4
Packaging Problem 4 4
Partial Blockage 4 4
Obstruction of Flow 4 4
Tear, Rip or Hole in Device Packaging 4 4
Delivered as Unsterile Product 3 3
Material Protrusion/Extrusion 3 3
Use of Device Problem 3 3
Thickening of Material 3 3
Improper Flow or Infusion 3 3
Material Frayed 2 2
Unsealed Device Packaging 2 2
Material Integrity Problem 2 2
Unintended Movement 2 2
Device Dislodged or Dislocated 2 2
Difficult to Open or Remove Packaging Material 2 2
Biocompatibility 2 2
Contamination /Decontamination Problem 2 2
Device Markings/Labelling Problem 2 2
Disconnection 1 1
Difficult to Open or Close 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 1174 1177
Mitral Valve Insufficiency/ Regurgitation 414 414
No Information 190 190
Non specific EKG/ECG Changes 165 165
Atrial Fibrillation 132 132
Mitral Regurgitation 121 121
Heart Block 108 108
No Clinical Signs, Symptoms or Conditions 82 82
Tricuspid Valve Insufficiency/ Regurgitation 79 79
Mitral Valve Stenosis 76 77
Stroke/CVA 73 73
Hemorrhage/Bleeding 53 53
Dyspnea 49 49
Tachycardia 49 49
Endocarditis 49 49
Heart Failure/Congestive Heart Failure 43 43
Bradycardia 34 34
Cardiomyopathy 31 31
Pericardial Effusion 31 31
Pleural Effusion 28 28
Atrial Flutter 24 24
Unspecified Infection 19 19
Tricuspid Regurgitation 19 19
Myocardial Infarction 19 19
Low Cardiac Output 18 18
Anemia 16 16
Blood Loss 16 16
Valvular Insufficiency/ Regurgitation 16 16
Pneumothorax 16 16
Transient Ischemic Attack 15 15
Arrhythmia 15 15
Aortic Valve Insufficiency/ Regurgitation 14 15
Coagulation Disorder 13 13
Hematoma 13 13
Renal Failure 12 12
Hemothorax 11 11
Cardiac Arrest 10 10
Respiratory Failure 10 10
Post Operative Wound Infection 9 9
Ventricular Fibrillation 9 9
Cusp Tear 9 10
Thrombosis/Thrombus 9 9
Chest Pain 9 9
Thromboembolism 9 9
Congestive Heart Failure 8 8
Hemolysis 8 8
No Known Impact Or Consequence To Patient 8 8
Calcium Deposits/Calcification 7 7
Death 7 7
Sepsis 7 7

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