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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
TAMABIO
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 80 81
2022 77 80
2023 40 40
2024 49 49
2025 122 122
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 107 107
Incomplete or Missing Packaging 100 100
Device Contamination with Chemical or Other Material 54 54
Insufficient Information 26 26
Product Quality Problem 14 18
Nonstandard Device 13 13
Missing Information 13 13
Difficult to Open or Remove Packaging Material 12 12
Unsealed Device Packaging 12 12
Off-Label Use 11 11
Material Split, Cut or Torn 6 6
Leak/Splash 5 5
Tear, Rip or Hole in Device Packaging 5 5
Fluid/Blood Leak 4 4
Packaging Problem 4 4
Material Rupture 4 4
Device Appears to Trigger Rejection 3 3
Appropriate Term/Code Not Available 3 3
Patient Device Interaction Problem 3 3
Patient-Device Incompatibility 3 3
Use of Device Problem 2 2
Obstruction of Flow 2 2
Lack of Effect 2 2
Material Integrity Problem 2 2
Material Puncture/Hole 2 2
Material Disintegration 2 5
Migration 2 2
Peeled/Delaminated 2 2
Calcified 2 2
Improper or Incorrect Procedure or Method 2 2
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Degraded 1 1
Unraveled Material 1 1
Material Too Rigid or Stiff 1 1
Contamination /Decontamination Problem 1 1
Delivered as Unsterile Product 1 1
Contamination 1 1
Device Handling Problem 1 1
Restricted Flow rate 1 1
Output Problem 1 1
Break 1 1
Unexpected Therapeutic Results 1 1
Fungus in Device Environment 1 1
Optical Discoloration 1 1
Incomplete Coaptation 1 1
Separation Problem 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 204 205
Stenosis 42 42
Insufficient Information 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Restenosis 10 10
Unspecified Infection 9 9
Hematoma 9 9
Pseudoaneurysm 8 8
Aneurysm 7 7
Failure of Implant 6 9
Thrombosis/Thrombus 6 6
Pulmonary Valve Insufficiency/ Regurgitation 5 5
Hemorrhage/Bleeding 5 5
Aortic Valve Insufficiency/ Regurgitation 4 4
Valvular Insufficiency/ Regurgitation 4 4
Rupture 4 4
Meningitis 4 4
Unspecified Tissue Injury 3 3
Pain 3 3
Dyspnea 3 3
Nerve Damage 3 3
Chest Pain 3 3
Pericardial Effusion 3 3
Obstruction/Occlusion 3 3
Adhesion(s) 3 3
Bacterial Infection 2 2
Unspecified Respiratory Problem 2 2
Inflammation 2 2
Aortic Valve Stenosis 2 2
Pleural Effusion 2 2
Fungal Infection 2 2
Mitral Valve Insufficiency/ Regurgitation 2 2
Sepsis 2 2
Endocarditis 2 2
Wound Dehiscence 2 2
Heart Failure/Congestive Heart Failure 2 2
Infiltration into Tissue 1 1
Ascites 1 1
Headache 1 1
Granuloma 1 1
Low Oxygen Saturation 1 1
Tissue Breakdown 1 1
Fistula 1 1
Calcium Deposits/Calcification 1 1
Muscle/Tendon Damage 1 1
Asystole 1 1
Fluid Discharge 1 1
Failure to Anastomose 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Artivion, Inc II Aug-08-2024
2 Baxter Healthcare Corporation II Jan-05-2024
3 Glycar SA Pty., Ltd. I Nov-25-2025
4 Vascutek, Ltd. II Sep-24-2021
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