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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 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1276 1278
Adverse Event Without Identified Device or Use Problem 583 585
Patient Device Interaction Problem 342 342
Central Regurgitation 193 193
Inadequacy of Device Shape and/or Size 94 94
Lack of Effect 45 45
Material Separation 38 38
Appropriate Term/Code Not Available 37 37
Device Stenosis 29 29
Backflow 28 28
Gradient Increase 23 24
Fluid/Blood Leak 22 23
Break 19 19
Incomplete Coaptation 18 18
Perivalvular Leak 18 18
Detachment of Device or Device Component 18 18
Leak/Splash 15 15
Patient-Device Incompatibility 9 9
Material Split, Cut or Torn 8 8
Calcified 8 8
Structural Problem 7 7
Improper or Incorrect Procedure or Method 6 6
Thickening of Material 5 5
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
Material Protrusion/Extrusion 3 3
Delivered as Unsterile Product 3 3
Improper Flow or Infusion 3 3
Use of Device Problem 3 3
Contamination /Decontamination Problem 2 2
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
Particulates 1 1
Difficult to Remove 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Device 1 1
Expiration Date Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1200 1203
Mitral Valve Insufficiency/ Regurgitation 433 433
No Information 190 190
Non specific EKG/ECG Changes 168 168
Atrial Fibrillation 139 139
Mitral Regurgitation 121 121
Heart Block 114 114
No Clinical Signs, Symptoms or Conditions 82 82
Tricuspid Valve Insufficiency/ Regurgitation 81 81
Mitral Valve Stenosis 79 80
Stroke/CVA 74 74
Hemorrhage/Bleeding 54 54
Tachycardia 52 52
Endocarditis 50 50
Dyspnea 50 50
Heart Failure/Congestive Heart Failure 44 44
Bradycardia 34 34
Pericardial Effusion 32 32
Cardiomyopathy 31 31
Pleural Effusion 28 28
Atrial Flutter 27 27
Unspecified Infection 19 19
Myocardial Infarction 19 19
Tricuspid Regurgitation 19 19
Valvular Insufficiency/ Regurgitation 18 18
Low Cardiac Output 18 18
Pneumothorax 16 16
Anemia 16 16
Blood Loss 16 16
Arrhythmia 15 15
Aortic Valve Insufficiency/ Regurgitation 15 16
Transient Ischemic Attack 15 15
Hematoma 14 14
Coagulation Disorder 13 13
Renal Failure 12 12
Hemothorax 11 11
Respiratory Failure 10 10
Calcium Deposits/Calcification 10 10
Cardiac Arrest 10 10
Chest Pain 9 9
Thrombosis/Thrombus 9 9
Ventricular Fibrillation 9 9
Thromboembolism 9 9
Post Operative Wound Infection 9 9
Cusp Tear 9 10
Hemolysis 8 8
Congestive Heart Failure 8 8
No Known Impact Or Consequence To Patient 8 8
Swelling/ Edema 7 7
Tricuspid Valve Stenosis 7 7

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