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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
CRYOLIFE, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCUTEK LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 30 30
2018 44 44
2019 55 55
2020 121 183
2021 80 80
2022 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 152 204
Device Contamination with Chemical or Other Material 40 40
Insufficient Information 32 32
Off-Label Use 26 34
Nonstandard Device 16 16
Difficult to Open or Remove Packaging Material 12 12
Improper or Incorrect Procedure or Method 12 12
Material Split, Cut or Torn 10 10
Peeled/Delaminated 9 9
Use of Device Problem 7 9
Appropriate Term/Code Not Available 6 6
Material Puncture/Hole 5 5
Fluid Leak 5 5
Detachment of Device or Device Component 5 5
Tear, Rip or Hole in Device Packaging 5 5
Material Integrity Problem 5 5
Product Quality Problem 4 4
Material Separation 4 4
Calcified 4 4
Migration or Expulsion of Device 4 4
Patient-Device Incompatibility 4 4
Patient Device Interaction Problem 4 4
Packaging Problem 4 4
Delamination 4 4
Material Rupture 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Contamination /Decontamination Problem 3 3
Thickening of Material 3 3
Structural Problem 3 3
Crack 3 3
Material Disintegration 3 3
Leak/Splash 3 3
Material Deformation 3 3
Missing Information 2 2
Unsealed Device Packaging 2 2
Material Too Rigid or Stiff 2 2
Hole In Material 2 2
Break 2 2
Delivered as Unsterile Product 2 2
Material Distortion 2 2
Material Erosion 2 2
Material Frayed 1 1
Moisture Damage 1 1
Incomplete Coaptation 1 1
Degraded 1 1
Shipping Damage or Problem 1 1
Microbial Contamination of Device 1 1
Obstruction of Flow 1 1
Device Dislodged or Dislocated 1 1
Output Problem 1 1
Torn Material 1 1
No Apparent Adverse Event 1 1
Separation Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Incomplete or Missing Packaging 1 1
Fracture 1 1
Device Fell 1 1
Partial Blockage 1 1
Unexpected Therapeutic Results 1 1
Device Sensing Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Stenosis 57 81
No Clinical Signs, Symptoms or Conditions 45 45
Unspecified Infection 24 24
No Patient Involvement 19 19
Pseudoaneurysm 14 14
No Code Available 14 14
Inflammation 14 14
No Consequences Or Impact To Patient 13 13
Aortic Valve Insufficiency/ Regurgitation 12 17
Hematoma 11 11
Aneurysm 11 11
Hemorrhage/Bleeding 10 15
Restenosis 10 33
No Known Impact Or Consequence To Patient 10 10
No Information 9 9
Mitral Valve Insufficiency/ Regurgitation 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Thrombosis/Thrombus 8 18
Aortic Valve Stenosis 8 8
Pain 8 8
Mitral Valve Stenosis 7 7
Insufficient Information 7 9
Not Applicable 6 6
Injury 6 6
Reaction 6 6
Wound Dehiscence 6 6
Adhesion(s) 6 6
Abscess 5 5
Arrhythmia 5 10
Death 5 5
Endocarditis 5 5
Failure of Implant 5 5
Sepsis 5 15
Seroma 5 5
Thrombus 4 4
Pericardial Effusion 4 4
Valvular Insufficiency/ Regurgitation 4 11
Blood Loss 4 4
Pulmonary Valve Insufficiency/ Regurgitation 4 4
Unspecified Respiratory Problem 3 15
Unspecified Tissue Injury 3 3
Swelling 3 3
Pneumonia 3 14
Nerve Damage 3 3
Fistula 3 3
Foreign Body Reaction 3 3
Aortic Insufficiency 3 3
Erosion 3 3
Calcium Deposits/Calcification 3 3
Cardiac Arrest 2 2
Chest Pain 2 2
Erythema 2 2
Exsanguination 2 2
Cardiac Tamponade 2 2
Impaired Healing 2 2
Post Operative Wound Infection 2 2
Drug Resistant Bacterial Infection 2 2
Pulmonary Hypertension 2 2
Respiratory Insufficiency 2 2
Low Cardiac Output 2 23
Valvular Stenosis 2 2
Vascular Dissection 1 1
Fluid Discharge 1 1
Patient Problem/Medical Problem 1 1
Organ Dehiscence 1 1
Chemical Exposure 1 1
Failure to Anastomose 1 1
Pericarditis 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Aortic Dissection 1 1
Meningitis 1 1
Fungal Infection 1 1
Obstruction/Occlusion 1 1
Hernia 1 1
Discomfort 1 1
Tricuspid Regurgitation 1 1
Rupture 1 1
Occlusion 1 1
Peripheral Vascular Disease 1 1
Pleural Effusion 1 1
Myocardial Infarction 1 1
Infiltration into Tissue 1 1
Pulmonary Valve Stenosis 1 1
Local Reaction 1 1
Respiratory Distress 1 1
Scar Tissue 1 1
Seizures 1 1
Thrombosis 1 1
Dyspnea 1 1
Hyperplasia 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoxia 1 1
Insufficiency, Valvular 1 1
Ischemia 1 1
Left Ventricular Dysfunction 1 1
Mitral Insufficiency 1 1
Mitral Regurgitation 1 1
Congenital Defect/Deformity 1 1
Cyst(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CryoLife, Inc. II Dec-21-2020
2 CryoLife, Inc. II Apr-25-2019
3 CryoLife, Inc. II Oct-18-2018
4 CryoLife, Inc. II Jun-21-2018
5 GETINGE US SALES LLC II Mar-20-2018
6 Vascutek, Ltd. II Sep-24-2021
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