• 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 heart-valve, non-allograft tissue
Product CodeLWR
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
50 32 18 37 26 14

MDR Year MDR Reports MDR Events
2019 1855 1855
2020 1437 1437
2021 1550 1550
2022 1084 1084
2023 1593 1593
2024 549 549

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3031 3031
Adverse Event Without Identified Device or Use Problem 935 935
Material Split, Cut or Torn 711 711
Gradient Increase 702 702
Degraded 643 643
Perivalvular Leak 615 615
Calcified 563 563
Patient-Device Incompatibility 419 419
Backflow 378 378
Obstruction of Flow 367 367
Incomplete Coaptation 323 323
Central Regurgitation 316 316
Patient Device Interaction Problem 305 305
Fluid/Blood Leak 288 288
Device Stenosis 251 251
Inadequacy of Device Shape and/or Size 243 243
Biocompatibility 138 138
Leak/Splash 116 116
Difficult to Open or Close 116 116
Detachment of Device or Device Component 83 83
Material Deformation 81 81
Appropriate Term/Code Not Available 77 77
Collapse 61 61
Material Separation 52 52
Off-Label Use 50 50
Device Dislodged or Dislocated 48 48
Material Too Rigid or Stiff 37 37
Malposition of Device 35 35
Migration 28 28
Material Puncture/Hole 28 28
Material Perforation 23 23
Partial Blockage 23 23
Positioning Failure 23 23
Difficult to Fold, Unfold or Collapse 21 21
Migration or Expulsion of Device 19 19
Therapeutic or Diagnostic Output Failure 19 19
Infusion or Flow Problem 18 18
Material Integrity Problem 18 18
Microbial Contamination of Device 16 16
Use of Device Problem 16 16
Improper or Incorrect Procedure or Method 15 15
Structural Problem 14 14
Material Twisted/Bent 14 14
Improper Flow or Infusion 12 12
Reflux within Device 12 12
Material Rupture 12 12
Break 12 12
Difficult or Delayed Separation 11 11
Thickening of Material 11 11
No Apparent Adverse Event 10 10
Fracture 9 9
Stretched 8 8
Activation Failure 8 8
Naturally Worn 8 8
Separation Problem 8 8
Positioning Problem 7 7
Unintended Movement 7 7
Defective Device 7 7
Tear, Rip or Hole in Device Packaging 6 6
Mechanical Jam 6 6
Missing Information 6 6
Human-Device Interface Problem 5 5
Contamination /Decontamination Problem 5 5
Entrapment of Device 5 5
Nonstandard Device 4 4
Peeled/Delaminated 4 4
Expiration Date Error 4 4
Product Quality Problem 4 4
Device Damaged by Another Device 4 4
Scratched Material 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Activation, Positioning or Separation Problem 3 3
Gas/Air Leak 3 3
Physical Resistance/Sticking 3 3
Device Appears to Trigger Rejection 3 3
Device Damaged Prior to Use 3 3
Mechanical Problem 3 3
Pitted 2 2
Unsealed Device Packaging 2 2
Material Invagination 2 2
Material Frayed 2 2
Complete Blockage 2 2
Difficult or Delayed Positioning 2 2
Burst Container or Vessel 2 2
Defective Component 2 2
Dent in Material 2 2
Unstable 2 2
Insufficient Flow or Under Infusion 2 2
Fitting Problem 2 2
Device Contaminated at the User Facility 2 2
Wrong Label 2 2
Device-Device Incompatibility 2 2
Packaging Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Misassembly by Users 1 1
Device Contaminated During Manufacture or Shipping 1 1
Output Problem 1 1
Difficult to Advance 1 1
Free or Unrestricted Flow 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1874 1874
Aortic Valve Insufficiency/ Regurgitation 1211 1211
Aortic Valve Stenosis 1108 1108
No Information 770 770
Dyspnea 619 619
Endocarditis 591 591
Aortic Regurgitation 513 513
Heart Failure/Congestive Heart Failure 496 496
Aortic Insufficiency 482 482
No Clinical Signs, Symptoms or Conditions 338 338
No Known Impact Or Consequence To Patient 255 255
Complete Heart Block 250 250
Death 233 233
Calcium Deposits/Calcification 213 213
Hemorrhage/Bleeding 210 210
Stroke/CVA 188 188
Mitral Valve Insufficiency/ Regurgitation 188 188
Thrombosis/Thrombus 149 149
Heart Block 145 145
Atrial Fibrillation 127 127
Heart Failure 111 111
Mitral Valve Stenosis 105 105
Fatigue 105 105
Non specific EKG/ECG Changes 103 103
Pulmonary Valve Stenosis 103 103
Mitral Regurgitation 95 95
Arrhythmia 89 90
Renal Failure 81 82
Corneal Pannus 80 80
Valvular Insufficiency/ Regurgitation 80 80
Chest Pain 79 79
Cusp Tear 78 78
Stenosis 78 78
Myocardial Infarction 74 74
Unspecified Infection 72 72
Thrombus 67 68
Obstruction/Occlusion 62 62
Pseudoaneurysm 56 56
Cardiogenic Shock 51 51
No Consequences Or Impact To Patient 50 50
Cardiac Arrest 50 50
Thrombosis 46 46
Bradycardia 45 45
No Code Available 45 45
Pulmonary Valve Insufficiency/ Regurgitation 43 43
Low Blood Pressure/ Hypotension 43 43
Fever 42 42
Insufficiency, Valvular 41 41
Sepsis 41 41
Low Cardiac Output 41 41
Pulmonary Edema 40 40
Pulmonary Regurgitation 40 40
Rupture 40 40
Aneurysm 40 40
Regurgitation 39 39
Thrombocytopenia 39 39
Congestive Heart Failure 37 37
Failure of Implant 37 37
Abscess 36 36
Thromboembolism 36 36
Pleural Effusion 35 35
Angina 34 34
Blood Loss 33 33
Regurgitation, Valvular 32 32
Cardiac Tamponade 30 30
Hematoma 28 28
Foreign Body Reaction 28 28
Transient Ischemic Attack 27 27
High Blood Pressure/ Hypertension 26 26
Host-Tissue Reaction 26 26
Ventricular Fibrillation 25 25
Pulmonary Insufficiency 25 25
Pericardial Effusion 25 25
Tachycardia 24 24
Dizziness 21 21
Tricuspid Valve Insufficiency/ Regurgitation 21 21
Swelling/ Edema 20 20
Vascular Dissection 20 20
Laceration(s) 20 20
Hemolysis 20 20
Respiratory Failure 19 19
Valvular Stenosis 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Bacterial Infection 17 17
Syncope/Fainting 15 15
Hemolytic Anemia 15 15
Anemia 13 13
Mitral Insufficiency 13 13
Perforation 13 13
Tricuspid Valve Stenosis 13 13
Tricuspid Regurgitation 12 12
Pneumonia 12 12
Ischemia 12 12
Syncope 12 12
Embolism 12 12
Vascular System (Circulation), Impaired 12 12
Pulmonary Hypertension 12 12
Respiratory Insufficiency 11 11
Embolism/Embolus 11 11
Multiple Organ Failure 11 11

Recalls
Manufacturer Recall Class Date Posted
1 Sorin Group Italia S.r.l. II Sep-18-2020
-
-