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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
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
ATRIUM MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HEMOSHPERE, INC., A CRYOLIFE COMPANY
  SUBSTANTIALLY EQUIVALENT 1
HEMOSPHERE INC
  SUBSTANTIALLY EQUIVALENT 3
INTERVASCULAR, SAS
  SUBSTANTIALLY EQUIVALENT 1
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CARDIOVASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CARDIOVASCULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
PECA LABS
  SUBSTANTIALLY EQUIVALENT 4
PECA LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TAYSIDE FLOW TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 2
VASCULAR FLOW TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 3
VASCUTEK LTD
  SUBSTANTIALLY EQUIVALENT 1
VASCUTEK LTD.
  SUBSTANTIALLY EQUIVALENT 6
W. L. GORE & ASSOCIATES INC.
  SUBSTANTIALLY EQUIVALENT 1
W. L. GORE & ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 2
W.L. GORE & ASSOCIATES
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 349 349
2015 460 460
2016 216 216
2017 193 193
2018 200 200
2019 232 232
2020 169 169
2021 168 168
2022 155 155
2023 149 149
2024 72 72

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 368 368
Adverse Event Without Identified Device or Use Problem 309 309
Appropriate Term/Code Not Available 169 169
Occlusion Within Device 152 152
Manufacturing, Packaging or Shipping Problem 133 133
Device Operates Differently Than Expected 127 127
Obstruction of Flow 101 101
Peeled/Delaminated 99 99
Leak/Splash 81 81
Complete Blockage 78 78
Material Integrity Problem 70 70
Material Split, Cut or Torn 68 68
Patient-Device Incompatibility 65 65
Torn Material 64 64
Material Separation 53 53
Material Puncture/Hole 50 50
Contamination 41 41
Microbial Contamination of Device 41 41
Product Quality Problem 40 40
Fluid/Blood Leak 30 30
Partial Blockage 27 27
Nonstandard Device 27 27
Patient Device Interaction Problem 24 24
Kinked 22 22
Hole In Material 22 22
Material Deformation 20 20
Use of Device Problem 19 19
Material Perforation 19 19
Migration or Expulsion of Device 18 18
Off-Label Use 18 18
Mechanical Problem 17 17
Flaked 17 17
Break 17 17
Unraveled Material 16 16
Delamination 15 15
Material Rupture 14 14
Infusion or Flow Problem 14 14
Detachment Of Device Component 13 13
Material Frayed 13 13
Device Contamination with Chemical or Other Material 12 12
Detachment of Device or Device Component 11 11
Defective Device 9 9
Migration 9 9
Device Damaged Prior to Use 9 9
Difficult to Remove 9 9
Shipping Damage or Problem 8 8
Device Handling Problem 8 8
Improper or Incorrect Procedure or Method 7 7
Entrapment of Device 7 7
No Apparent Adverse Event 7 7
Device Stenosis 6 6
Disconnection 6 6
Positioning Problem 6 6
No Flow 5 5
Human-Device Interface Problem 5 5
Improper Flow or Infusion 5 5
Activation, Positioning or Separation Problem 5 5
Degraded 5 5
Stretched 5 5
Delivered as Unsterile Product 5 5
Inadequacy of Device Shape and/or Size 4 4
Device Slipped 4 4
Material Discolored 4 4
Fracture 4 4
Contamination /Decontamination Problem 4 4
Device Markings/Labelling Problem 4 4
Device Damaged by Another Device 4 4
Device Packaging Compromised 4 4
Device Dislodged or Dislocated 4 4
Packaging Problem 4 4
Inaccurate Information 4 4
Material Protrusion/Extrusion 3 3
Material Twisted/Bent 3 3
Output Problem 3 3
Device Disinfection Or Sterilization Issue 3 3
Deformation Due to Compressive Stress 3 3
Structural Problem 3 3
Crack 3 3
Sticking 3 3
Unexpected Therapeutic Results 3 3
Device Appears to Trigger Rejection 2 2
Loose or Intermittent Connection 2 2
Difficult To Position 2 2
Difficult or Delayed Positioning 2 2
Device Alarm System 2 2
Material Fragmentation 2 2
Difficult to Insert 2 2
Material Disintegration 2 2
Failure to Advance 2 2
Split 2 2
Physical Resistance 2 2
Tear, Rip or Hole in Device Packaging 2 2
Component Missing 2 2
Folded 2 2
Biocompatibility 2 2
Connection Problem 2 2
Device Contamination With Biological Material 2 2
Extrusion 2 2
Compatibility Problem 2 2
Material Too Soft/Flexible 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 277 277
Thrombosis 228 228
Death 210 210
No Clinical Signs, Symptoms or Conditions 170 170
Blood Loss 147 147
No Consequences Or Impact To Patient 141 141
Hemorrhage/Bleeding 137 137
No Information 135 135
No Known Impact Or Consequence To Patient 121 121
Seroma 120 120
Occlusion 112 112
No Code Available 104 104
Hematoma 96 96
Thrombosis/Thrombus 92 92
Pseudoaneurysm 86 86
Stenosis 83 83
Thrombus 73 73
Bacterial Infection 73 73
No Patient Involvement 62 62
Obstruction/Occlusion 49 49
Insufficient Information 37 37
Ischemia 36 36
Failure of Implant 34 34
Pain 31 31
Aneurysm 23 23
Swelling 22 22
Vascular System (Circulation), Impaired 20 20
Abscess 19 19
Fever 17 17
Foreign Body In Patient 17 17
Vascular Dissection 16 16
Impaired Healing 16 16
Sepsis 16 16
Complaint, Ill-Defined 16 16
Inflammation 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Cardiac Arrest 14 14
Renal Failure 14 14
Pulmonary Embolism 13 13
Failure to Anastomose 12 12
Tissue Damage 12 12
Post Operative Wound Infection 11 11
Edema 11 11
Low Blood Pressure/ Hypotension 10 10
Necrosis 10 10
Sudden Cardiac Death 10 10
Wound Dehiscence 9 9
Myocardial Infarction 8 8
Fistula 8 8
High Blood Pressure/ Hypertension 8 8
Rupture 8 8
Staphylococcus Aureus 7 7
Injury 7 7
Reaction 7 7
Patient Problem/Medical Problem 7 7
Not Applicable 6 6
Numbness 6 6
Hypersensitivity/Allergic reaction 6 6
Foreign Body Reaction 6 6
Embolism 6 6
Purulent Discharge 5 5
Infarction, Cerebral 5 5
Abdominal Pain 5 5
Erosion 5 5
Exsanguination 5 5
Reocclusion 5 5
Fungal Infection 5 5
Low Oxygen Saturation 5 5
Aortic Dissection 5 5
Multiple Organ Failure 5 5
Ischemia Stroke 4 4
Test Result 4 4
Heart Failure/Congestive Heart Failure 4 4
Fluid Discharge 4 4
Collapse 4 4
Pneumonia 4 4
Perforation of Vessels 4 4
Arrhythmia 4 4
Chest Pain 4 4
Dyspnea 4 4
Embolus 4 4
Erythema 3 3
Air Embolism 3 3
Fall 3 3
Hyperplasia 3 3
Perforation 3 3
Respiratory Distress 3 3
Discomfort 3 3
Device Embedded In Tissue or Plaque 3 3
Unspecified Vascular Problem 2 2
Syncope/Fainting 2 2
Swelling/ Edema 2 2
Ulcer 2 2
Hypovolemia 2 2
Infection, Indirect 2 2
Cardiogenic Shock 2 2
Hematuria 2 2
Thromboembolism 2 2
Tissue Breakdown 2 2
Cardiac Perforation 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Sep-29-2021
2 Atrium Medical Corporation II Sep-30-2013
3 Bard Peripheral Vascular Inc II Feb-09-2016
4 Intervascular S.A.S. II Apr-28-2010
5 Intervascular S.A.S. II Apr-23-2010
6 Maquet Cardiovascular, LLC II Mar-10-2023
7 Maquet Cardiovascular, LLC II Jun-23-2022
8 Maquet Cardiovascular, LLC II Mar-07-2011
9 Maquet Cardiovascular, LLC II Jul-22-2010
10 Maquet Cardiovascular, LLC II May-14-2010
11 Maquet Cardiovascular, LLC II Feb-26-2010
12 Terumo Cardiovascular Systems Corporation II Nov-18-2013
13 Vascutek, Ltd. II Sep-24-2021
14 Vascutek, Ltd. II Aug-18-2014
15 W L Gore & Associates, Inc. II Aug-13-2021
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