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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 80 80

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Failure 762 762
Misfire 694 694
Fracture 485 485
Break 300 300
Adverse Event Without Identified Device or Use Problem 194 194
Detachment of Device or Device Component 142 142
Material Perforation 141 141
Obstruction of Flow 124 124
Activation Failure 112 112
Material Deformation 97 97
Malposition of Device 78 78
Complete Blockage 76 76
Difficult to Remove 75 75
Loss of or Failure to Bond 72 72
Difficult or Delayed Positioning 64 64
Retraction Problem 55 55
Patient-Device Incompatibility 48 48
Insufficient Information 48 48
Positioning Problem 42 42
Difficult to Advance 40 40
Activation, Positioning or Separation Problem 36 36
Migration or Expulsion of Device 32 32
Entrapment of Device 31 31
Failure to Advance 29 29
Material Separation 27 27
Premature Activation 26 26
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 13 13
Failure to Unfold or Unwrap 12 12
Device Dislodged or Dislocated 11 11
Off-Label Use 10 10
Deformation Due to Compressive Stress 9 9
Material Twisted/Bent 9 9
Material Split, Cut or Torn 9 9
Packaging Problem 8 8
Device Damaged by Another Device 8 8
Device Markings/Labelling Problem 7 7
Leak/Splash 7 7
Bent 6 6
Mechanical Problem 6 6
Device Operates Differently Than Expected 6 6
Patient Device Interaction Problem 6 6
No Apparent Adverse Event 6 6
Device Stenosis 5 5
Difficult or Delayed Separation 5 5
Physical Resistance/Sticking 5 5
Microbial Contamination of Device 5 5
Material Fragmentation 5 5
Fluid/Blood Leak 5 5
Material Puncture/Hole 4 4
Use of Device Problem 4 4
Material Rupture 4 4
Physical Resistance 4 4
Failure to Deliver 4 4
Self-Activation or Keying 3 3
Stretched 3 3
Component Missing 3 3
Device Damaged Prior to Use 3 3
Kinked 3 3
Hole In Material 3 3
Difficult to Insert 3 3
Human-Device Interface Problem 3 3
Difficult to Open or Close 3 3
Unintended Movement 3 3
Material Integrity Problem 2 2
Separation Problem 2 2
Premature Separation 2 2
Inaccurate Information 2 2
Missing Information 2 2
Material Erosion 2 2
Collapse 2 2
Detachment Of Device Component 2 2
Device Difficult to Setup or Prepare 2 2
Device Slipped 2 2
Sticking 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Contamination with Body Fluid 2 2
Contamination /Decontamination Problem 2 2
Split 1 1
Structural Problem 1 1
Unexpected Therapeutic Results 1 1
Inadequacy of Device Shape and/or Size 1 1
Defective Component 1 1
Out-Of-Box Failure 1 1
Unsealed Device Packaging 1 1
Failure to Reset 1 1
Flushing Problem 1 1
Optical Decentration 1 1
Poor Quality Image 1 1
Nonstandard Device 1 1
Crack 1 1
Disconnection 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 669 669
Occlusion 137 137
No Known Impact Or Consequence To Patient 133 133
Stenosis 87 87
Restenosis 87 87
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 29 29
Unspecified Infection 23 23
Injury 22 22
Thrombosis/Thrombus 22 22
Perforation of Vessels 20 20
Hemorrhage/Bleeding 20 20
Death 20 20
Pseudoaneurysm 19 19
Device Embedded In Tissue or Plaque 19 19
Foreign Body In Patient 19 19
No Information 19 19
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
Insufficient Information 8 8
Vascular System (Circulation), Impaired 7 7
Hematoma 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 4 4
Device Overstimulation of Tissue 3 3
Renal Failure 3 3
Multiple Organ Failure 3 3
Rupture 3 3
Great Vessel Perforation 2 2
Cramp(s) 2 2
Seroma 2 2
Skin Discoloration 2 2
Skin Erosion 2 2
Reocclusion 2 2
Hepatitis 2 2
Abdominal Pain 2 2
Abscess 2 2
Cardiac Arrest 2 2
Stroke/CVA 2 2
Embolism/Embolus 2 2
Renal Impairment 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Skin Infection 1 1
Implant Pain 1 1
Infarction, Cerebral 1 1
Edema 1 1
Fever 1 1
Anemia 1 1
Wound Dehiscence 1 1
Intimal Dissection 1 1
Radiation Overdose 1 1
Calcium Deposits/Calcification 1 1
Atherosclerosis 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Necrosis 1 1
Gangrene 1 1
Headache 1 1
Hemorrhage, Cerebral 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
Arteriosclerosis/ Atherosclerosis 1 1
Ascites 1 1
Confusion/ Disorientation 1 1
Lethargy 1 1
Paraplegia 1 1
Respiratory Failure 1 1

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