• 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 pulmonary valve prosthesis percutaneously delivered
Definition These devices are intended to replace a patient's pulmonary heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
Product CodeNPV
Device Class Humanitarian Device Exemption

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
5 2 4 7 16 17

MDR Year MDR Reports MDR Events
2017 96 96
2018 129 129
2019 144 144
2020 115 115
2021 161 161
2022 107 107

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 200 200
Adverse Event Without Identified Device or Use Problem 151 151
Gradient Increase 126 126
Fracture 120 120
Perivalvular Leak 42 42
Obstruction of Flow 39 39
Malposition of Device 38 38
Device Dislodged or Dislocated 34 34
Fluid Leak 28 28
Incomplete Coaptation 26 26
Calcified 20 20
Patient Device Interaction Problem 19 19
Material Separation 18 18
Burst Container or Vessel 17 17
Degraded 17 17
Migration 17 17
Appropriate Term/Code Not Available 16 16
Material Rupture 13 13
Migration or Expulsion of Device 13 13
Inadequacy of Device Shape and/or Size 12 12
Partial Blockage 9 9
Inflation Problem 8 8
Difficult to Remove 8 8
Positioning Problem 8 8
Material Deformation 8 8
No Apparent Adverse Event 7 7
Activation Failure 7 7
Material Split, Cut or Torn 6 6
Difficult to Advance 6 6
Deflation Problem 6 6
Leak/Splash 5 5
Difficult to Open or Close 5 5
Structural Problem 5 5
Material Integrity Problem 4 4
Mechanical Problem 4 4
Complete Blockage 4 4
Off-Label Use 4 4
Occlusion Within Device 3 3
Difficult or Delayed Positioning 3 3
Torn Material 3 3
Unintended Movement 3 3
Failure to Advance 3 3
Activation, Positioning or SeparationProblem 3 3
Device Damaged by Another Device 3 3
Device-Device Incompatibility 2 2
Deformation Due to Compressive Stress 2 2
Material Invagination 2 2
Break 2 2
Bent 2 2
Reflux within Device 2 2
Device Slipped 2 2
Use of Device Problem 2 2
Material Perforation 1 1
Failure to Deliver 1 1
Unintended Collision 1 1
Peeled/Delaminated 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Backflow 1 1
Crack 1 1
Positioning Failure 1 1
Material Fragmentation 1 1
Patient Data Problem 1 1
Physical Resistance/Sticking 1 1
Thickening of Material 1 1
Naturally Worn 1 1
Material Distortion 1 1
Detachment of Device or Device Component 1 1
Improper Flow or Infusion 1 1
Split 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Failure to Align 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pulmonary Valve Stenosis 105 105
Insufficient Information 104 104
Endocarditis 98 98
No Known Impact Or Consequence To Patient 95 95
No Information 82 82
No Clinical Signs, Symptoms or Conditions 61 61
Stenosis 55 55
Pulmonary Regurgitation 55 55
Pulmonary Valve Insufficiency/ Regurgitation 42 42
Injury 34 34
Obstruction/Occlusion 33 33
Vascular System (Circulation), Impaired 21 21
No Consequences Or Impact To Patient 20 20
Rupture 19 19
Regurgitation, Valvular 19 19
Mitral Regurgitation 19 19
No Code Available 18 18
Thrombus 17 17
Death 15 15
Non specific EKG/ECG Changes 15 15
Insufficiency, Valvular 14 14
Mitral Valve Stenosis 13 13
Pulmonary Insufficiency 13 13
Hemorrhage/Bleeding 13 13
Blood Loss 13 13
Valvular Insufficiency/ Regurgitation 12 12
Aortic Regurgitation 12 12
Calcium Deposits/Calcification 12 12
Tricuspid Regurgitation 12 12
High Blood Pressure/ Hypertension 11 11
Thrombosis/Thrombus 11 11
Aortic Valve Stenosis 10 10
Corneal Pannus 9 9
Stroke/CVA 9 9
Unspecified Infection 9 9
Heart Failure/Congestive Heart Failure 9 9
Pseudoaneurysm 9 9
Regurgitation 9 9
Ventricular Tachycardia 8 8
Arrhythmia 8 8
Fatigue 7 7
Pulmonary Edema 7 7
Low Cardiac Output 7 7
Vascular Dissection 7 7
Cardiovascular Insufficiency 7 7
Heart Block 6 6
Tricuspid Valve Insufficiency/ Regurgitation 6 6
Occlusion 6 6
Failure of Implant 6 6
Right Ventricular Dysfunction 6 6
Congestive Heart Failure 6 6
Cardiac Arrest 6 6
Fistula 5 5
Tachycardia 5 5
Hematoma 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Valvular Stenosis 5 5
Complete Heart Block 5 5
Unspecified Heart Problem 4 4
Low Blood Pressure/ Hypotension 4 4
Mitral Insufficiency 4 4
Perforation 4 4
Sepsis 4 4
Dyspnea 4 4
Pulmonary Embolism 4 4
Bacterial Infection 3 3
Bradycardia 3 3
Embolism 3 3
Right Ventricular Hypertrophy 3 3
Tricuspid Insufficiency 3 3
Pulmonary Dysfunction 3 3
Respiratory Insufficiency 3 3
Unspecified Tissue Injury 3 3
Pericardial Effusion 3 3
Foreign Body In Patient 3 3
Ventricular Fibrillation 3 3
Great Vessel Perforation 3 3
Heart Failure 3 3
Respiratory Failure 2 2
Patient Problem/Medical Problem 2 2
Thromboembolism 2 2
Cardiac Perforation 2 2
Unspecified Vascular Problem 2 2
Swelling/ Edema 2 2
Aortic Valve Insufficiency/ Regurgitation 2 2
Pleural Effusion 2 2
Myocardial Infarction 2 2
Inflammation 2 2
Ischemia 2 2
Tricuspid Valve Stenosis 2 2
Fever 2 2
Host-Tissue Reaction 2 2
Chest Pain 2 2
Congenital Defect/Deformity 2 2
Aneurysm 2 2
Atrial Fibrillation 2 2
Atrial Flutter 1 1
Aortic Insufficiency 1 1
Anemia 1 1
Erosion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc I Apr-18-2022
-
-