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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, vascular graft, of 6mm and greater diameter
Product CodeDSY
Regulation Number 870.3450
Device Class 2


Premarket Reviews
ManufacturerDecision
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PECA LABS
  SUBSTANTIALLY EQUIVALENT 3
PECA LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCUTEK LTD
  SUBSTANTIALLY EQUIVALENT 1
W. L. GORE & ASSOCIATES INC.
  SUBSTANTIALLY EQUIVALENT 1
W. L. GORE & ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 2
W.L. GORE & ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 232 232
2020 169 169
2021 168 168
2022 155 155
2023 149 149
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 129 129
Insufficient Information 89 89
Peeled/Delaminated 71 71
Material Split, Cut or Torn 58 58
Obstruction of Flow 57 57
Patient-Device Incompatibility 46 46
Material Integrity Problem 45 45
Material Puncture/Hole 39 39
Complete Blockage 37 37
Microbial Contamination of Device 37 37
Product Quality Problem 34 34
Contamination 32 32
Manufacturing, Packaging or Shipping Problem 31 31
Nonstandard Device 25 25
Patient Device Interaction Problem 24 24
Appropriate Term/Code Not Available 19 19
Material Separation 19 19
Leak/Splash 17 17
Partial Blockage 17 17
Off-Label Use 17 17
Use of Device Problem 16 16
Flaked 15 15
Material Perforation 14 14
Mechanical Problem 13 13
Material Deformation 12 12
Fluid/Blood Leak 10 10
Device Damaged Prior to Use 9 9
Defective Device 9 9
Migration 9 9
Infusion or Flow Problem 8 8
Shipping Damage or Problem 7 7
Detachment of Device or Device Component 6 6
Material Rupture 5 5
Device Handling Problem 5 5
Inaccurate Information 4 4
Device Stenosis 4 4
Contamination /Decontamination Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Material Frayed 4 4
Difficult to Remove 3 3
Human-Device Interface Problem 3 3
Device Markings/Labelling Problem 3 3
Unraveled Material 3 3
Deformation Due to Compressive Stress 3 3
No Apparent Adverse Event 3 3
Material Twisted/Bent 2 2
Material Too Soft/Flexible 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Biocompatibility 2 2
Device Damaged by Another Device 2 2
Compatibility Problem 2 2
Output Problem 2 2
Packaging Problem 2 2
Device Appears to Trigger Rejection 2 2
Stretched 2 2
Unexpected Therapeutic Results 2 2
Delivered as Unsterile Product 2 2
Fracture 2 2
Material Fragmentation 2 2
Crack 2 2
Device Alarm System 2 2
Disconnection 2 2
Material Disintegration 1 1
No Display/Image 1 1
Backflow 1 1
Material Discolored 1 1
Gradient Increase 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Material Invagination 1 1
Device Difficult to Setup or Prepare 1 1
Material Too Rigid or Stiff 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Protrusion/Extrusion 1 1
Improper Flow or Infusion 1 1
Activation, Positioning or Separation Problem 1 1
Structural Problem 1 1
Failure to Advance 1 1
Separation Failure 1 1
Fitting Problem 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
No Flow 1 1
Failure to Seal 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 144 144
Unspecified Infection 112 112
Thrombosis/Thrombus 76 76
Hemorrhage/Bleeding 67 67
Obstruction/Occlusion 45 45
No Consequences Or Impact To Patient 44 44
Stenosis 42 42
Bacterial Infection 36 36
Hematoma 35 35
Occlusion 34 34
Blood Loss 33 33
Insufficient Information 32 32
Pseudoaneurysm 27 27
No Patient Involvement 27 27
Seroma 26 26
Death 23 23
Thrombosis 22 22
No Known Impact Or Consequence To Patient 22 22
No Information 19 19
No Code Available 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Aneurysm 13 13
Vascular Dissection 12 12
Ischemia 10 10
Thrombus 10 10
Post Operative Wound Infection 8 8
Pain 7 7
Failure of Implant 7 7
Inflammation 6 6
Sepsis 6 6
Renal Failure 6 6
Swelling 5 5
Failure to Anastomose 5 5
Wound Dehiscence 4 4
Abdominal Pain 4 4
Rupture 4 4
Ischemia Stroke 4 4
Heart Failure/Congestive Heart Failure 4 4
Perforation of Vessels 3 3
Foreign Body In Patient 3 3
Fistula 3 3
Hypersensitivity/Allergic reaction 3 3
High Blood Pressure/ Hypertension 2 2
Low Blood Pressure/ Hypotension 2 2
Paresis 2 2
Perforation 2 2
Rash 2 2
Local Reaction 2 2
Erosion 2 2
Cardiac Arrest 2 2
Purulent Discharge 2 2
Exsanguination 2 2
Embolism 2 2
Fungal Infection 2 2
Quadriplegia 2 2
Thromboembolism 2 2
Infection, Indirect 2 2
Unspecified Vascular Problem 2 2
Swelling/ Edema 2 2
Syncope/Fainting 2 2
Peripheral Edema 1 1
Asystole 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Ruptured Aneurysm 1 1
Device Embedded In Tissue or Plaque 1 1
Unspecified Heart Problem 1 1
Liver Failure 1 1
Unspecified Hepatic or Biliary Problem 1 1
Unspecified Kidney or Urinary Problem 1 1
Blister 1 1
Drug Resistant Bacterial Infection 1 1
Pyogenic Infection 1 1
Cardiogenic Shock 1 1
Injury 1 1
Reaction 1 1
Discharge 1 1
Cardiac Tamponade 1 1
Heart Failure 1 1
Vomiting 1 1
Urinary Tract Infection 1 1
Respiratory Distress 1 1
Fluid Discharge 1 1
Aortic Dissection 1 1
Sudden Cardiac Death 1 1
Cardiac Perforation 1 1
Patient Problem/Medical Problem 1 1
Cancer 1 1
Pericardial Effusion 1 1
Embolus 1 1
Endocarditis 1 1
Erythema 1 1
Fever 1 1
Dyspnea 1 1
Chest Pain 1 1
Anemia 1 1
Myocardial Infarction 1 1
Hypovolemic Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Sep-29-2021
2 Maquet Cardiovascular, LLC II Mar-10-2023
3 Maquet Cardiovascular, LLC II Jun-23-2022
4 Vascutek, Ltd. II Sep-24-2021
5 W L Gore & Associates, Inc. II Aug-13-2021
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