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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ring, annuloplasty
Product CodeKRH
Regulation Number 870.3800
Device Class 2


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

MDR Year MDR Reports MDR Events
2019 349 349
2020 340 340
2021 423 423
2022 372 372
2023 325 325
2024 191 191

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1266 1266
Adverse Event Without Identified Device or Use Problem 579 579
Inadequacy of Device Shape and/or Size 118 118
Patient Device Interaction Problem 104 104
Material Separation 40 40
Central Regurgitation 38 38
Backflow 30 30
Gradient Increase 27 27
Detachment of Device or Device Component 24 24
Lack of Effect 22 22
Fluid/Blood Leak 21 21
Appropriate Term/Code Not Available 18 18
Incomplete Coaptation 14 14
Patient-Device Incompatibility 14 14
Perivalvular Leak 13 13
No Apparent Adverse Event 12 12
Device Stenosis 9 9
Material Split, Cut or Torn 9 9
Improper or Incorrect Procedure or Method 9 9
Obstruction of Flow 8 8
Degraded 7 7
Off-Label Use 6 6
Calcified 6 6
Leak/Splash 5 5
Delivered as Unsterile Product 4 4
Reflux within Device 4 4
Partial Blockage 4 4
Fracture 4 4
Use of Device Problem 4 4
Device Markings/Labelling Problem 4 4
Material Deformation 4 4
Improper Flow or Infusion 3 3
Difficult to Open or Remove Packaging Material 3 3
Unintended Movement 3 3
Tear, Rip or Hole in Device Packaging 3 3
Structural Problem 3 3
Break 3 3
Unsealed Device Packaging 3 3
Device Appears to Trigger Rejection 2 2
Material Frayed 2 2
Biocompatibility 2 2
Packaging Problem 2 2
Material Protrusion/Extrusion 2 2
Separation Problem 2 2
Thickening of Material 2 2
Inaccurate Information 1 1
Material Twisted/Bent 1 1
Output Problem 1 1
Device Dislodged or Dislocated 1 1
Difficult to Open or Close 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Expiration Date Error 1 1
Material Perforation 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Labelling, Instructions for Use or Training Problem 1 1
Disconnection 1 1
Difficult to Remove 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 832 832
No Information 438 438
Mitral Valve Insufficiency/ Regurgitation 289 289
Mitral Regurgitation 229 229
Atrial Fibrillation 91 91
Non specific EKG/ECG Changes 89 89
Mitral Valve Stenosis 86 86
Stroke/CVA 59 59
Heart Block 58 58
Endocarditis 53 53
No Clinical Signs, Symptoms or Conditions 51 51
Tricuspid Valve Insufficiency/ Regurgitation 47 47
Hemorrhage/Bleeding 40 40
Dyspnea 38 38
Pericardial Effusion 31 31
Heart Failure/Congestive Heart Failure 29 29
Tricuspid Regurgitation 29 29
No Known Impact Or Consequence To Patient 26 26
Bradycardia 21 21
Pleural Effusion 20 20
Unspecified Infection 19 19
Low Cardiac Output 19 19
Blood Loss 18 18
Mitral Insufficiency 17 17
Myocardial Infarction 17 17
Pneumothorax 15 15
Tachycardia 15 15
Mitral Valve Prolapse 14 14
Anemia 14 14
Coagulation Disorder 14 14
Congestive Heart Failure 14 14
Arrhythmia 13 13
Transient Ischemic Attack 13 13
Complete Heart Block 10 10
Hematoma 10 10
Renal Failure 9 9
Death 9 9
Thromboembolism 9 9
Valvular Insufficiency/ Regurgitation 9 9
Respiratory Failure 9 9
Ventricular Fibrillation 8 8
Host-Tissue Reaction 8 8
Calcium Deposits/Calcification 8 8
Atrial Flutter 8 8
Hemolysis 7 7
Hemothorax 7 7
No Consequences Or Impact To Patient 7 7
Hemolytic Anemia 7 7
Rupture 6 6
Cardiac Tamponade 6 6
Tricuspid Valve Stenosis 6 6
Sepsis 6 6
Cardiac Arrest 6 6
Corneal Pannus 6 6
Foreign Body Reaction 5 5
Ischemia 5 5
Thrombosis 5 5
Regurgitation 5 5
Cardiogenic Shock 5 5
Aortic Valve Insufficiency/ Regurgitation 5 5
Pseudoaneurysm 5 5
Post Operative Wound Infection 5 5
Swelling/ Edema 5 5
Confusion/ Disorientation 4 4
Cusp Tear 4 4
No Code Available 4 4
Stenosis 4 4
Prolapse 4 4
Nausea 4 4
Right Ventricular Dysfunction 4 4
Pulmonary Edema 4 4
Low Blood Pressure/ Hypotension 4 4
Cardiomyopathy 4 4
Chest Pain 4 4
Fatigue 4 4
Fever 3 3
Aortic Valve Stenosis 3 3
Aneurysm 3 3
High Blood Pressure/ Hypertension 3 3
Inflammation 3 3
Failure of Implant 3 3
Headache 3 3
Pneumonia 3 3
Muscle Weakness 3 3
Obstruction/Occlusion 3 3
Aortic Dissection 3 3
Regurgitation, Valvular 3 3
Tricuspid Insufficiency 3 3
Ischemia Stroke 3 3
Embolism/Embolus 3 3
Thrombosis/Thrombus 3 3
Fibrosis 3 3
Convulsion/Seizure 3 3
Presyncope 2 2
Vascular Dissection 2 2
Foreign Body In Patient 2 2
Vascular System (Circulation), Impaired 2 2
Ascites 2 2
Cardiovascular Insufficiency 2 2
Unspecified Heart Problem 2 2

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