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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
Regulation Description Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
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
2020 121 183
2021 80 80
2022 77 77
2023 40 40
2024 49 49
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 169 221
Device Contamination with Chemical or Other Material 56 56
Insufficient Information 27 27
Off-Label Use 26 34
Product Quality Problem 14 14
Nonstandard Device 13 13
Improper or Incorrect Procedure or Method 13 13
Difficult to Open or Remove Packaging Material 12 12
Unsealed Device Packaging 8 8
Use of Device Problem 7 9
Peeled/Delaminated 6 6
Material Split, Cut or Torn 6 6
Tear, Rip or Hole in Device Packaging 6 6
Material Rupture 5 5
Leak/Splash 4 4
Packaging Problem 4 4
Fluid/Blood Leak 4 4
Appropriate Term/Code Not Available 4 4
Material Disintegration 3 3
Thickening of Material 3 3
Patient Device Interaction Problem 3 3
Material Puncture/Hole 3 3
Migration 2 2
Lack of Effect 2 2
Material Too Rigid or Stiff 2 2
Structural Problem 2 2
Material Integrity Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Obstruction of Flow 2 2
Contamination /Decontamination Problem 2 2
Break 2 2
Detachment of Device or Device Component 2 2
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Delivered as Unsterile Product 1 1
Contamination 1 1
Degraded 1 1
Calcified 1 1
Material Erosion 1 1
Device Sensing Problem 1 1
Output Problem 1 1
Material Separation 1 1
Biocompatibility 1 1
Partial Blockage 1 1
Separation Problem 1 1
Device Handling Problem 1 1
Fungus in Device Environment 1 1
Unexpected Therapeutic Results 1 1
Material Frayed 1 1
Optical Discoloration 1 1
Incomplete Coaptation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 96 96
Stenosis 64 88
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Insufficient Information 19 21
Restenosis 15 38
Aortic Valve Insufficiency/ Regurgitation 14 19
Thrombosis/Thrombus 12 22
Unspecified Infection 11 11
Hematoma 10 10
Pseudoaneurysm 10 10
Mitral Valve Insufficiency/ Regurgitation 10 10
Aortic Valve Stenosis 9 9
Mitral Valve Stenosis 7 7
Inflammation 7 7
Hemorrhage/Bleeding 6 11
Failure of Implant 6 6
Endocarditis 6 6
Injury 6 6
Aneurysm 6 6
Pain 5 5
Sepsis 5 15
Arrhythmia 5 10
No Patient Involvement 5 5
Pulmonary Valve Insufficiency/ Regurgitation 5 5
Valvular Insufficiency/ Regurgitation 5 12
Seroma 4 4
Meningitis 4 4
Rupture 4 4
Wound Dehiscence 4 4
Pericardial Effusion 4 4
Dyspnea 3 3
Death 3 3
Chest Pain 3 3
Unspecified Tissue Injury 3 3
Adhesion(s) 3 3
Unspecified Respiratory Problem 3 15
Not Applicable 3 3
No Known Impact Or Consequence To Patient 3 3
Reaction 3 3
Pneumonia 3 14
Nerve Damage 3 3
No Code Available 2 2
Pulmonary Hypertension 2 2
Respiratory Insufficiency 2 2
Valvular Stenosis 2 2
Impaired Healing 2 2
Bacterial Infection 2 2
Drug Resistant Bacterial Infection 2 2
Cardiac Arrest 2 2
Pleural Effusion 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Artivion, Inc II Aug-08-2024
2 Baxter Healthcare Corporation II Jan-05-2024
3 CryoLife, Inc. II Dec-21-2020
4 Vascutek, Ltd. II Sep-24-2021
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