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 pulmonic valved conduit
Product CodeMWH
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2019 128 128
2020 83 83
2021 79 79
2022 67 67
2023 57 57
2024 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 297 297
Gradient Increase 66 66
Calcified 47 47
Adverse Event Without Identified Device or Use Problem 37 37
Patient Device Interaction Problem 28 28
Obstruction of Flow 28 28
Device Stenosis 19 19
Central Regurgitation 17 17
Inadequacy of Device Shape and/or Size 16 16
Material Deformation 11 11
Degraded 10 10
Partial Blockage 6 6
Incomplete Coaptation 6 6
Stretched 4 4
Device Markings/Labelling Problem 4 4
Material Split, Cut or Torn 4 4
No Apparent Adverse Event 3 3
Reflux within Device 3 3
Leak/Splash 2 2
Unsealed Device Packaging 2 2
Peeled/Delaminated 2 2
Biocompatibility 2 2
Thickening of Material 2 2
Fracture 2 2
Appropriate Term/Code Not Available 1 1
Deformation Due to Compressive Stress 1 1
Device Dislodged or Dislocated 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Perivalvular Leak 1 1
Break 1 1
Material Erosion 1 1
Material Separation 1 1
Expiration Date Error 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pulmonary Valve Stenosis 168 168
Insufficient Information 138 138
No Information 118 118
Pulmonary Valve Insufficiency/ Regurgitation 75 75
Endocarditis 58 58
Pulmonary Regurgitation 37 37
Pulmonary Insufficiency 21 21
Obstruction/Occlusion 20 20
Non specific EKG/ECG Changes 19 19
Calcium Deposits/Calcification 16 16
Stenosis 14 14
Unspecified Infection 12 12
Fever 12 12
Thrombosis/Thrombus 11 11
Aneurysm 10 10
Thrombus 8 8
Blood Loss 8 8
Hemorrhage/Bleeding 8 8
Low Cardiac Output 7 7
Sepsis 7 7
Stroke/CVA 7 7
Heart Block 7 7
Dyspnea 6 6
Tachycardia 6 6
Death 6 6
Pseudoaneurysm 6 6
Regurgitation, Valvular 6 6
Pleural Effusion 5 5
Low Blood Pressure/ Hypotension 5 5
Heart Failure/Congestive Heart Failure 5 5
Cardiac Arrest 5 5
Complete Heart Block 5 5
Thromboembolism 5 5
Fibrosis 4 4
Aortic Valve Stenosis 4 4
No Known Impact Or Consequence To Patient 4 4
Abscess 4 4
Ventricular Fibrillation 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Aortic Regurgitation 3 3
Myocardial Infarction 3 3
Vascular System (Circulation), Impaired 3 3
Respiratory Insufficiency 3 3
Unspecified Heart Problem 3 3
Hematoma 3 3
Pericardial Effusion 3 3
Arrhythmia 3 3
Ventricular Tachycardia 3 3
Bradycardia 3 3
Intimal Dissection 3 3

-
-