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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
2024 6 6

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 57 57
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
Tear, Rip or Hole in Device Packaging 7 7
Use of Device Problem 7 9
Material Split, Cut or Torn 6 6
Material Rupture 6 6
Fluid/Blood Leak 5 5
Detachment of Device or Device Component 5 5
Appropriate Term/Code Not Available 5 5
Patient Device Interaction Problem 5 5
Packaging Problem 4 4
Leak/Splash 4 4
Calcified 4 4
Product Quality Problem 4 4
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
Thickening of Material 3 3
Material Deformation 3 3
Contamination /Decontamination Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Delivered as Unsterile Product 2 2
Crack 2 2
Degraded 2 2
Patient-Device Incompatibility 2 2
Obstruction of Flow 2 2
Material Too Rigid or Stiff 2 2
Material Separation 2 2
Shipping Damage or Problem 1 1
Unexpected Therapeutic Results 1 1
Incomplete or Missing Packaging 1 1
Fungus in Device Environment 1 1
Biocompatibility 1 1
Incomplete Coaptation 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
Output Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Device Handling Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Sensing Problem 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 78 78
Stenosis 67 91
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Unspecified Infection 18 18
Inflammation 14 14
Aortic Valve Insufficiency/ Regurgitation 14 19
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
Endocarditis 7 7
Mitral Valve Stenosis 7 7
Pain 7 7
No Known Impact Or Consequence To Patient 7 7
Injury 6 6
Failure of Implant 6 6
Arrhythmia 5 10
Wound Dehiscence 5 5
Adhesion(s) 5 5
Aneurysm 5 5
Seroma 5 5
No Consequences Or Impact To Patient 5 5
Valvular Insufficiency/ Regurgitation 5 12
Sepsis 4 14
Pulmonary Valve Insufficiency/ Regurgitation 4 4
Pericardial Effusion 4 4
Rupture 4 4
Meningitis 4 4
Reaction 4 4
Death 4 4
Dyspnea 3 3
Foreign Body Reaction 3 3
Aortic Insufficiency 3 3
Calcium Deposits/Calcification 3 3
Chest Pain 3 3
Pneumonia 3 14
Nerve Damage 3 3
Not Applicable 3 3
Unspecified Respiratory Problem 3 15
Unspecified Tissue Injury 3 3
Drug Resistant Bacterial Infection 2 2
Pulmonary Hypertension 2 2
Respiratory Insufficiency 2 2
No Information 2 2
Valvular Stenosis 2 2
Cardiac Tamponade 2 2
Thrombus 2 2
Impaired Healing 2 2
Low Cardiac Output 2 23
Cardiac Arrest 2 2
Exsanguination 2 2
Bacterial Infection 2 2
Erosion 1 1
Bradycardia 1 6
Atrial Fibrillation 1 1
Fatigue 1 1
Fistula 1 1
Failure to Anastomose 1 1
Granuloma 1 1
Hyperplasia 1 1
Hypersensitivity/Allergic reaction 1 1
Insufficiency, Valvular 1 1
Infiltration into Tissue 1 1
Ischemia 1 1
Left Ventricular Dysfunction 1 1
Mitral Insufficiency 1 1
Mitral Regurgitation 1 1
Chemical Exposure 1 1
Blood Loss 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
Swelling 1 1
Thrombosis 1 1
Hernia 1 1
Occlusion 1 1
Myocardial Infarction 1 1
Pulmonary Valve Stenosis 1 1
Local Reaction 1 1
Pleural Effusion 1 1
Vascular Dissection 1 1
Embolism/Embolus 1 1
Heart Failure/Congestive Heart Failure 1 1
Pericarditis 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
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