Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device replacement heart-valve
Definition Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))
Product CodeDYE
Regulation Number 870.3925
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
16 13 7 8 11 5

MDR Year MDR Reports MDR Events
2019 2820 2820
2020 2466 2466
2021 2833 2833
2022 2566 2566
2023 3495 3495
2024 1099 1099

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 6532 6532
Gradient Increase 5527 5527
Degraded 2556 2556
Fluid/Blood Leak 2358 2358
Calcified 1876 1876
Adverse Event Without Identified Device or Use Problem 1862 1862
Appropriate Term/Code Not Available 1142 1142
Incomplete Coaptation 799 799
Patient Device Interaction Problem 604 604
Device Stenosis 582 582
Difficult to Open or Close 565 565
Perivalvular Leak 514 514
Central Regurgitation 283 283
Material Split, Cut or Torn 201 201
Structural Problem 171 171
Inadequacy of Device Shape and/or Size 131 131
Patient-Device Incompatibility 104 104
Detachment of Device or Device Component 74 74
Therapeutic or Diagnostic Output Failure 68 68
Obstruction of Flow 61 61
Unintended Movement 49 49
Thickening of Material 44 44
Leak/Splash 35 35
Entrapment of Device 28 28
Material Separation 28 28
Material Deformation 28 28
Off-Label Use 26 26
Break 22 22
Mechanical Jam 19 19
Fracture 18 18
Material Puncture/Hole 17 17
Material Perforation 17 17
Naturally Worn 17 17
Microbial Contamination of Device 16 16
Defective Device 16 16
Material Integrity Problem 15 15
Contamination /Decontamination Problem 12 12
Material Too Rigid or Stiff 12 12
Malposition of Device 11 11
Backflow 10 10
Partial Blockage 10 10
Mechanical Problem 8 8
No Apparent Adverse Event 8 8
Positioning Problem 7 7
Physical Resistance/Sticking 7 7
Pitted 7 7
Defective Component 7 7
Particulates 6 6
Contamination 6 6
Material Twisted/Bent 6 6
Protective Measures Problem 6 6
Device Dislodged or Dislocated 5 5
Separation Problem 5 5
Migration or Expulsion of Device 5 5
Reflux within Device 5 5
Material Rupture 4 4
Unraveled Material 3 3
Improper or Incorrect Procedure or Method 3 3
Biocompatibility 3 3
Device Damaged by Another Device 3 3
Device Contamination with Chemical or Other Material 3 3
Improper Flow or Infusion 3 3
Material Protrusion/Extrusion 3 3
Missing Information 3 3
Compatibility Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Packaging Problem 2 2
Device-Device Incompatibility 2 2
Difficult to Advance 2 2
Device Markings/Labelling Problem 2 2
Activation, Positioning or Separation Problem 2 2
Expiration Date Error 2 2
Use of Device Problem 2 2
Material Invagination 2 2
Delivered as Unsterile Product 2 2
Restricted Flow rate 2 2
Inaccurate Flow Rate 1 1
Material Erosion 1 1
Flaked 1 1
Crack 1 1
Difficult or Delayed Positioning 1 1
Disconnection 1 1
Premature Discharge of Battery 1 1
Complete Blockage 1 1
Coagulation in Device or Device Ingredient 1 1
Collapse 1 1
Unsealed Device Packaging 1 1
Product Quality Problem 1 1
Nonstandard Device 1 1
Loose or Intermittent Connection 1 1
Material Fragmentation 1 1
Insufficient Heating 1 1
Difficult to Insert 1 1
Insufficient Flow or Under Infusion 1 1
Device Damaged Prior to Use 1 1
Stretched 1 1
Unexpected Therapeutic Results 1 1
Device Appears to Trigger Rejection 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 6173 6173
Aortic Valve Stenosis 3145 3148
Heart Failure/Congestive Heart Failure 2197 2197
Dyspnea 1850 1851
Mitral Valve Stenosis 1090 1094
Aortic Regurgitation 1061 1061
Stenosis 953 953
Aortic Valve Insufficiency/ Regurgitation 948 948
No Known Impact Or Consequence To Patient 719 719
Regurgitation 653 653
Mitral Regurgitation 648 651
No Information 561 561
Endocarditis 423 423
Calcium Deposits/Calcification 299 302
Aortic Insufficiency 296 296
Fatigue 274 274
No Code Available 262 262
Chest Pain 211 212
Pulmonary Valve Stenosis 192 192
No Clinical Signs, Symptoms or Conditions 190 190
Failure of Implant 170 170
Congestive Heart Failure 159 160
Mitral Valve Insufficiency/ Regurgitation 138 138
Pulmonary Regurgitation 132 133
Non specific EKG/ECG Changes 127 127
Dizziness 120 120
Death 118 118
Tricuspid Valve Stenosis 115 115
Hemorrhage/Bleeding 104 104
Syncope/Fainting 103 103
Cardiogenic Shock 102 102
Atrial Fibrillation 101 101
Corneal Pannus 94 94
Tricuspid Regurgitation 84 84
Thrombosis/Thrombus 79 79
Stroke/CVA 76 76
Cusp Tear 74 74
Heart Block 73 73
Regurgitation, Valvular 65 65
Thrombus 64 69
Valvular Insufficiency/ Regurgitation 60 60
Swelling/ Edema 59 59
Insufficiency, Valvular 56 56
Heart Failure 53 53
Thrombosis 50 50
Unspecified Infection 41 41
Cardiac Arrest 39 40
Complete Heart Block 37 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Pulmonary Valve Insufficiency/ Regurgitation 35 35
Low Blood Pressure/ Hypotension 35 35
Mitral Insufficiency 31 31
Obstruction/Occlusion 31 31
Sepsis 30 30
Foreign Body Reaction 28 28
Myocardial Infarction 25 25
Pulmonary Hypertension 25 25
Peripheral Edema 24 24
Blood Loss 24 24
Pulmonary Insufficiency 24 24
Rupture 24 24
Pleural Effusion 23 23
Low Cardiac Output 23 23
Tachycardia 22 22
High Blood Pressure/ Hypertension 22 22
Abscess 22 22
Renal Failure 21 21
Occlusion 20 20
Angina 20 20
Bradycardia 20 20
Arrhythmia 19 19
Pulmonary Edema 19 19
Valvular Stenosis 19 19
Presyncope 18 18
Thromboembolism 18 18
Organ Dehiscence 18 18
Aneurysm 18 18
Fever 18 18
Hematoma 17 17
Respiratory Failure 17 17
Pericardial Effusion 17 17
Vascular Dissection 16 16
Pseudoaneurysm 16 16
Tricuspid Valve Insufficiency/ Regurgitation 16 16
Host-Tissue Reaction 16 16
Hypoxia 13 13
Wound Dehiscence 12 12
Bacterial Infection 11 11
Patient Problem/Medical Problem 11 11
Hemolytic Anemia 11 11
Transient Ischemic Attack 10 10
Ventricular Fibrillation 9 9
Tissue Damage 9 9
Pneumonia 9 9
Cardiomyopathy 9 9
Anemia 9 9
Atrial Flutter 8 8
Cardiac Tamponade 8 8
Multiple Organ Failure 8 8
Cough 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc II Jun-26-2019
-
-