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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment
Definition An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.
Product CodePFV
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
5 7 4 5 7 17 12 14 13 17 13 12 12 8 9 2

MDR Year MDR Reports MDR Events
2014 1 1
2015 54 54
2016 82 82
2017 195 195
2018 343 343
2019 376 376
2020 337 337
2021 281 281
2022 261 261
2023 229 229
2024 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Failure 748 748
Misfire 683 683
Fracture 476 476
Break 294 294
Adverse Event Without Identified Device or Use Problem 185 185
Material Perforation 139 139
Detachment of Device or Device Component 137 137
Obstruction of Flow 124 124
Activation Failure 106 106
Material Deformation 96 96
Complete Blockage 76 76
Difficult to Remove 74 74
Loss of or Failure to Bond 72 72
Malposition of Device 72 72
Difficult or Delayed Positioning 63 63
Retraction Problem 55 55
Patient-Device Incompatibility 48 48
Insufficient Information 48 48
Difficult to Advance 40 40
Positioning Problem 40 40
Activation, Positioning or Separation Problem 36 36
Entrapment of Device 31 31
Migration or Expulsion of Device 30 30
Failure to Advance 29 29
Material Separation 27 27
Premature Activation 25 25
Device-Device Incompatibility 24 24
Improper or Incorrect Procedure or Method 21 21
Difficult or Delayed Activation 21 21
Separation Failure 20 20
Material Invagination 20 20
Occlusion Within Device 18 18
Partial Blockage 14 14
Appropriate Term/Code Not Available 14 14
Migration 14 14
Activation Problem 12 12
Failure to Unfold or Unwrap 12 12
Device Dislodged or Dislocated 11 11
Off-Label Use 10 10
Material Split, Cut or Torn 9 9
Device Damaged by Another Device 8 8
Packaging Problem 8 8
Material Twisted/Bent 8 8
Deformation Due to Compressive Stress 8 8
Device Markings/Labelling Problem 7 7
Leak/Splash 7 7
Bent 6 6
Device Operates Differently Than Expected 6 6
Mechanical Problem 6 6
No Apparent Adverse Event 6 6
Patient Device Interaction Problem 6 6
Microbial Contamination of Device 5 5
Fluid/Blood Leak 5 5
Material Puncture/Hole 4 4
Material Fragmentation 4 4
Use of Device Problem 4 4
Material Rupture 4 4
Physical Resistance 4 4
Failure to Deliver 4 4
Difficult or Delayed Separation 4 4
Device Stenosis 4 4
Unintended Movement 3 3
Difficult to Open or Close 3 3
Human-Device Interface Problem 3 3
Self-Activation or Keying 3 3
Stretched 3 3
Device Damaged Prior to Use 3 3
Component Missing 3 3
Hole In Material 3 3
Difficult to Insert 3 3
Kinked 3 3
Device Difficult to Setup or Prepare 2 2
Material Erosion 2 2
Collapse 2 2
Detachment Of Device Component 2 2
Device Contamination with Body Fluid 2 2
Sticking 2 2
Tear, Rip or Hole in Device Packaging 2 2
Contamination /Decontamination Problem 2 2
Material Integrity Problem 2 2
Premature Separation 2 2
Inaccurate Information 2 2
Missing Information 2 2
Physical Resistance/Sticking 2 2
Separation Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Device Handling Problem 1 1
Infusion or Flow Problem 1 1
Mechanical Jam 1 1
Structural Problem 1 1
Split 1 1
Unexpected Therapeutic Results 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Out-Of-Box Failure 1 1
Defective Component 1 1
Crack 1 1
Disconnection 1 1
Material Disintegration 1 1
Labelling, Instructions for Use or Training Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 773 773
No Clinical Signs, Symptoms or Conditions 638 638
Occlusion 137 137
No Known Impact Or Consequence To Patient 133 133
Stenosis 87 87
Restenosis 78 78
No Code Available 45 45
Thrombosis 44 44
Aneurysm 43 43
Pain 32 32
Obstruction/Occlusion 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
Unspecified Infection 23 23
Injury 22 22
Hemorrhage/Bleeding 20 20
Death 20 20
Thrombosis/Thrombus 20 20
Perforation of Vessels 19 19
Pseudoaneurysm 19 19
Device Embedded In Tissue or Plaque 19 19
No Information 19 19
Foreign Body In Patient 18 18
No Patient Involvement 15 15
Thrombus 15 15
Ischemia 15 15
Embolism 12 12
Blood Loss 12 12
Claudication 9 9
Perforation 9 9
Fistula 8 8
Thromboembolism 8 8
Vascular Dissection 8 8
Vascular System (Circulation), Impaired 7 7
Hematoma 7 7
Insufficient Information 7 7
Sepsis 6 6
Unspecified Tissue Injury 5 5
Swelling/ Edema 4 4
Numbness 4 4
Not Applicable 4 4
Encephalopathy 4 4
Extravasation 4 4
Bacterial Infection 3 3
Renal Failure 3 3
Device Overstimulation of Tissue 3 3
Rupture 3 3
Multiple Organ Failure 3 3
Cramp(s) /Muscle Spasm(s) 2 2
Embolism/Embolus 2 2
Great Vessel Perforation 2 2
Cramp(s) 2 2
Seroma 2 2
Skin Discoloration 2 2
Skin Erosion 2 2
Reocclusion 2 2
Abscess 2 2
Hepatitis 2 2
Cardiac Arrest 2 2
Stroke/CVA 2 2
Infarction, Cerebral 1 1
Edema 1 1
Fever 1 1
Calcium Deposits/Calcification 1 1
Atherosclerosis 1 1
Wound Dehiscence 1 1
Intimal Dissection 1 1
Radiation Overdose 1 1
Abdominal Pain 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Hemorrhage, Cerebral 1 1
Gangrene 1 1
Headache 1 1
Necrosis 1 1
Staphylococcus Aureus 1 1
Phlebitis 1 1
Swelling 1 1
Tachycardia 1 1
Transient Ischemic Attack 1 1
Urinary Tract Infection 1 1
Fungal Infection 1 1
Complaint, Ill-Defined 1 1
Ascites 1 1
Confusion/ Disorientation 1 1
Lethargy 1 1
Paraplegia 1 1
Respiratory Failure 1 1
Skin Infection 1 1
Implant Pain 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Renal Impairment 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Feb-09-2023
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