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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
Regulation Description Vascular graft prosthesis.
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 2
PECA LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCUTEK LTD
  SUBSTANTIALLY EQUIVALENT 1
VASCUTEK LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
2020 169 169
2021 168 168
2022 155 155
2023 149 149
2024 155 155
2025 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 121 121
Peeled/Delaminated 91 91
Obstruction of Flow 69 69
Insufficient Information 56 56
Material Split, Cut or Torn 51 51
Patient-Device Incompatibility 47 47
Complete Blockage 42 42
Contamination 37 37
Material Integrity Problem 36 36
Microbial Contamination of Device 36 36
Material Puncture/Hole 34 34
Material Separation 30 30
Product Quality Problem 27 27
Nonstandard Device 24 24
Partial Blockage 20 20
Off-Label Use 19 19
Patient Device Interaction Problem 19 19
Flaked 17 17
Device Stenosis 16 16
Use of Device Problem 16 16
Leak/Splash 14 14
Fluid/Blood Leak 14 14
Material Deformation 11 11
Manufacturing, Packaging or Shipping Problem 11 11
Appropriate Term/Code Not Available 11 11
Material Perforation 10 10
Defective Device 10 10
Mechanical Problem 9 9
Device Damaged Prior to Use 9 9
Migration 9 9
Infusion or Flow Problem 8 8
Material Frayed 7 7
Material Rupture 6 6
Material Fragmentation 5 5
Inaccurate Information 5 5
Improper or Incorrect Procedure or Method 5 5
Contamination /Decontamination Problem 4 4
Shipping Damage or Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Detachment of Device or Device Component 4 4
Material Twisted/Bent 4 4
Device Markings/Labelling Problem 4 4
No Apparent Adverse Event 3 3
Human-Device Interface Problem 3 3
Labelling, Instructions for Use or Training Problem 3 3
Packaging Problem 3 3
Deformation Due to Compressive Stress 3 3
Compatibility Problem 3 3
Missing Information 2 2
Fracture 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 219 219
Thrombosis/Thrombus 105 105
Hemorrhage/Bleeding 90 90
Obstruction/Occlusion 61 61
Unspecified Infection 54 54
Insufficient Information 48 48
Bacterial Infection 43 43
Hematoma 33 33
Stenosis 32 32
Pseudoaneurysm 28 28
Seroma 23 23
No Consequences Or Impact To Patient 21 21
Occlusion 19 19
Thrombosis 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Ischemia 14 14
Vascular Dissection 13 13
No Code Available 13 13
No Patient Involvement 12 12
Aneurysm 11 11
Pain 9 9
Post Operative Wound Infection 9 9
Wound Dehiscence 8 8
Thrombus 8 8
Blood Loss 8 8
Failure of Implant 7 7
Inflammation 6 6
Death 6 6
Sepsis 5 5
No Information 5 5
Failure to Anastomose 5 5
Rupture 5 5
Swelling/ Edema 4 4
Heart Failure/Congestive Heart Failure 4 4
Ischemia Stroke 4 4
Abdominal Pain 4 4
Fever 4 4
Perforation of Vessels 3 3
Erosion 3 3
Renal Failure 3 3
Fistula 3 3
Foreign Body In Patient 3 3
Purulent Discharge 3 3
Hypersensitivity/Allergic reaction 3 3
No Known Impact Or Consequence To Patient 2 2
Rash 2 2
High Blood Pressure/ Hypertension 2 2
Syncope/Fainting 2 2
Quadriplegia 2 2
Low Blood Pressure/ Hypotension 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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