• 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 patch, pledget and intracardiac, petp, ptfe, polypropylene
Product CodeDXZ
Regulation Number 870.3470
Device Class 2


Premarket Reviews
ManufacturerDecision
ADMEDUS REGEN PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
VASCUTEK LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 55 55
2020 121 183
2021 80 80
2022 77 77
2023 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 159 211
Device Contamination with Chemical or Other Material 54 54
Insufficient Information 35 35
Off-Label Use 27 35
Nonstandard Device 13 13
Improper or Incorrect Procedure or Method 12 12
Difficult to Open or Remove Packaging Material 12 12
Peeled/Delaminated 8 8
Use of Device Problem 7 9
Tear, Rip or Hole in Device Packaging 7 7
Material Rupture 6 6
Material Split, Cut or Torn 6 6
Patient Device Interaction Problem 5 5
Detachment of Device or Device Component 5 5
Appropriate Term/Code Not Available 5 5
Fluid/Blood Leak 5 5
Calcified 4 4
Product Quality Problem 4 4
Packaging Problem 4 4
Material Deformation 3 3
Contamination /Decontamination Problem 3 3
Thickening of Material 3 3
Material Puncture/Hole 3 3
Structural Problem 3 3
Break 3 3
Material Disintegration 3 3
Migration or Expulsion of Device 3 3
Unsealed Device Packaging 3 3
Leak/Splash 2 2
Delivered as Unsterile Product 2 2
Crack 2 2
Degraded 2 2
Obstruction of Flow 2 2
Material Too Rigid or Stiff 2 2
Material Separation 2 2
Patient-Device Incompatibility 2 2
Material Integrity Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Handling Problem 1 1
Output Problem 1 1
Biocompatibility 1 1
Device Sensing Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Separation Problem 1 1
Shipping Damage or Problem 1 1
Unexpected Therapeutic Results 1 1
Incomplete Coaptation 1 1
Incomplete or Missing Packaging 1 1
Fungus in Device Environment 1 1
Material Erosion 1 1
Restricted Flow rate 1 1
Partial Blockage 1 1
Contamination 1 1
Moisture Damage 1 1
Fracture 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 75 75
Stenosis 67 91
Unspecified Infection 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Aortic Valve Insufficiency/ Regurgitation 14 19
Inflammation 14 14
Hematoma 11 11
Aortic Valve Stenosis 10 10
Pseudoaneurysm 10 10
Mitral Valve Insufficiency/ Regurgitation 10 10
Restenosis 10 33
Insufficient Information 9 11
Thrombosis/Thrombus 9 19
No Code Available 8 8
No Patient Involvement 8 8
Hemorrhage/Bleeding 8 13
Mitral Valve Stenosis 7 7
Endocarditis 7 7
No Known Impact Or Consequence To Patient 7 7
Pain 7 7
Injury 6 6
No Consequences Or Impact To Patient 5 5
Seroma 5 5
Arrhythmia 5 10
Wound Dehiscence 5 5
Adhesion(s) 5 5
Aneurysm 5 5
Failure of Implant 5 5
Death 4 4
Sepsis 4 14
Rupture 4 4
Meningitis 4 4
Reaction 4 4
Pericardial Effusion 4 4
Pulmonary Valve Insufficiency/ Regurgitation 4 4
Valvular Insufficiency/ Regurgitation 4 11
Unspecified Tissue Injury 3 3
Unspecified Respiratory Problem 3 15
Not Applicable 3 3
Pneumonia 3 14
Calcium Deposits/Calcification 3 3
Foreign Body Reaction 3 3
Aortic Insufficiency 3 3
Nerve Damage 3 3
Bacterial Infection 2 2
Exsanguination 2 2
Cardiac Arrest 2 2
Chest Pain 2 2
Dyspnea 2 2
Cardiac Tamponade 2 2
Impaired Healing 2 2
Thrombus 2 2
Valvular Stenosis 2 2
Low Cardiac Output 2 23
No Information 2 2
Pulmonary Hypertension 2 2
Respiratory Insufficiency 2 2
Drug Resistant Bacterial Infection 2 2
Heart Failure/Congestive Heart Failure 1 1
Pericarditis 1 1
Embolism/Embolus 1 1
Chemical Exposure 1 1
Blood Loss 1 1
Vascular Dissection 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Fungal Infection 1 1
Obstruction/Occlusion 1 1
Post Operative Wound Infection 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Aortic Dissection 1 1
Tricuspid Regurgitation 1 1
Hernia 1 1
Pulmonary Valve Stenosis 1 1
Local Reaction 1 1
Pleural Effusion 1 1
Failure to Anastomose 1 1
Swelling 1 1
Thrombosis 1 1
Fistula 1 1
Granuloma 1 1
Erosion 1 1
Bradycardia 1 6
Atrial Fibrillation 1 1
Occlusion 1 1
Myocardial Infarction 1 1
Ischemia 1 1
Left Ventricular Dysfunction 1 1
Mitral Insufficiency 1 1
Mitral Regurgitation 1 1
Insufficiency, Valvular 1 1
Infiltration into Tissue 1 1
Hyperplasia 1 1
Hypersensitivity/Allergic reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jan-05-2024
2 CryoLife, Inc. II Dec-21-2020
3 CryoLife, Inc. II Apr-25-2019
4 Vascutek, Ltd. II Sep-24-2021
-
-