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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 CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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 131 131

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 141 141
Insufficient Information 107 107
Peeled/Delaminated 92 92
Obstruction of Flow 73 73
Material Split, Cut or Torn 64 64
Patient-Device Incompatibility 50 50
Material Integrity Problem 47 47
Complete Blockage 43 43
Microbial Contamination of Device 42 42
Material Puncture/Hole 41 41
Contamination 37 37
Manufacturing, Packaging or Shipping Problem 36 36
Product Quality Problem 35 35
Material Separation 32 32
Nonstandard Device 25 25
Patient Device Interaction Problem 24 24
Appropriate Term/Code Not Available 22 22
Use of Device Problem 20 20
Off-Label Use 20 20
Partial Blockage 20 20
Leak/Splash 18 18
Flaked 16 16
Material Perforation 14 14
Device Stenosis 14 14
Mechanical Problem 13 13
Fluid/Blood Leak 13 13
Material Deformation 12 12
Defective Device 9 9
Migration 9 9
Device Damaged Prior to Use 9 9
Infusion or Flow Problem 8 8
Shipping Damage or Problem 7 7
Detachment of Device or Device Component 6 6
Inaccurate Information 5 5
Device Handling Problem 5 5
Material Fragmentation 5 5
Material Rupture 5 5
Material Frayed 5 5
Device Contamination with Chemical or Other Material 4 4
Contamination /Decontamination Problem 4 4
Improper or Incorrect Procedure or Method 4 4
No Apparent Adverse Event 3 3
Human-Device Interface Problem 3 3
Deformation Due to Compressive Stress 3 3
Compatibility Problem 3 3
Material Twisted/Bent 3 3
Unraveled Material 3 3
Stretched 3 3
Device Markings/Labelling Problem 3 3
Difficult to Remove 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 189 189
Unspecified Infection 119 119
Thrombosis/Thrombus 99 99
Hemorrhage/Bleeding 83 83
Obstruction/Occlusion 55 55
Stenosis 45 45
No Consequences Or Impact To Patient 44 44
Bacterial Infection 44 44
Insufficient Information 42 42
Hematoma 37 37
Occlusion 34 34
Blood Loss 33 33
Pseudoaneurysm 29 29
Seroma 28 28
No Patient Involvement 27 27
Death 23 23
Thrombosis 22 22
No Known Impact Or Consequence To Patient 22 22
No Code Available 19 19
No Information 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Aneurysm 15 15
Ischemia 14 14
Vascular Dissection 13 13
Pain 10 10
Post Operative Wound Infection 10 10
Thrombus 10 10
Inflammation 9 9
Wound Dehiscence 8 8
Failure of Implant 7 7
Sepsis 6 6
Renal Failure 6 6
Failure to Anastomose 5 5
Swelling 5 5
Swelling/ Edema 4 4
Rupture 4 4
Perforation of Vessels 4 4
Heart Failure/Congestive Heart Failure 4 4
Fever 4 4
Ischemia Stroke 4 4
Abdominal Pain 4 4
Erosion 3 3
Purulent Discharge 3 3
Hypersensitivity/Allergic reaction 3 3
Foreign Body In Patient 3 3
Fistula 3 3
Myocardial Infarction 2 2
Embolism 2 2
Thromboembolism 2 2
Unspecified Vascular Problem 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Jun-04-2024
2 Atrium Medical Corporation II Sep-29-2021
3 Maquet Cardiovascular, LLC II Mar-10-2023
4 Maquet Cardiovascular, LLC II Jun-23-2022
5 Vascutek, Ltd. II Sep-24-2021
6 W L Gore & Associates, Inc. II Aug-13-2021
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