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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)
2016 2017 2018 2019 2020 2021
14 13 17 13 12 12

MDR Year MDR Reports MDR Events
2016 82 82
2017 195 195
2018 343 343
2019 376 376
2020 337 337
2021 239 239

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Failure 493 493
Misfire 405 405
Fracture 362 362
Break 165 165
Material Perforation 107 107
Adverse Event Without Identified Device or Use Problem 107 107
Obstruction of Flow 98 98
Detachment of Device or Device Component 96 96
Activation Failure 76 76
Complete Blockage 73 73
Difficult to Remove 56 56
Difficult or Delayed Positioning 52 52
Retraction Problem 51 51
Malposition of Device 50 50
Material Deformation 47 47
Insufficient Information 45 45
Patient-Device Incompatibility 44 44
Activation, Positioning or SeparationProblem 34 34
Positioning Problem 33 33
Difficult to Advance 28 28
Migration or Expulsion of Device 25 25
Material Separation 24 24
Entrapment of Device 23 23
Failure to Advance 21 21
Difficult or Delayed Activation 19 19
Separation Failure 18 18
Improper or Incorrect Procedure or Method 18 18
Occlusion Within Device 18 18
Premature Activation 18 18
Material Invagination 17 17
Device-Device Incompatibility 17 17
Appropriate Term/Code Not Available 13 13
Failure to Unfold or Unwrap 12 12
Partial Blockage 10 10
Deformation Due to Compressive Stress 8 8
Device Dislodged or Dislocated 8 8
Device Damaged by Another Device 8 8
Migration 8 8
Material Split, Cut or Torn 8 8
Activation Problem 8 8
No Apparent Adverse Event 6 6
Packaging Problem 6 6
Bent 6 6
Leak/Splash 6 6
Mechanical Problem 6 6
Off-Label Use 6 6
Fluid Leak 5 5
Device Markings/Labelling Problem 5 5
Device Operates Differently Than Expected 5 5
Microbial Contamination of Device 5 5
Patient Device Interaction Problem 5 5
Material Twisted/Bent 4 4
Failure to Deliver 4 4
Use of Device Problem 4 4
Physical Resistance 4 4
Material Rupture 4 4
Material Fragmentation 4 4
Hole In Material 3 3
Human-Device Interface Problem 3 3
Difficult to Open or Close 3 3
Unintended Movement 3 3
Difficult or Delayed Separation 3 3
Premature Separation 2 2
Material Integrity Problem 2 2
Physical Resistance/Sticking 2 2
Device Damaged Prior to Use 2 2
Sticking 2 2
Component Missing 2 2
Device Contamination with Body Fluid 2 2
Material Erosion 2 2
Collapse 2 2
Detachment Of Device Component 2 2
Self-Activation or Keying 2 2
Material Puncture/Hole 2 2
Kinked 2 2
Optical Decentration 1 1
Nonstandard Device 1 1
Unsealed Device Packaging 1 1
Failure to Reset 1 1
Crack 1 1
Loss of or Failure to Bond 1 1
Disconnection 1 1
Material Disintegration 1 1
Difficult to Insert 1 1
Labelling, Instructions for Use or Training Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Stretched 1 1
Unexpected Therapeutic Results 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Infusion or Flow Problem 1 1
Contamination /Decontamination Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Device Handling Problem 1 1
Mechanical Jam 1 1
Inaccurate Information 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 730 730
No Clinical Signs, Symptoms or Conditions 193 193
Occlusion 137 137
No Known Impact Or Consequence To Patient 102 102
Stenosis 77 77
No Code Available 45 45
Thrombosis 44 44
Aneurysm 35 35
Pain 25 25
Injury 22 22
Unspecified Infection 21 21
Restenosis 21 21
Death 19 19
Device Embedded In Tissue or Plaque 19 19
No Information 18 18
Pseudoaneurysm 17 17
Perforation of Vessels 17 17
Obstruction/Occlusion 16 16
Thrombus 15 15
No Patient Involvement 15 15
Hemorrhage/Bleeding 14 14
Embolism 12 12
Blood Loss 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Foreign Body In Patient 11 11
Ischemia 11 11
Perforation 10 10
Claudication 9 9
Thromboembolism 8 8
Vascular System (Circulation), Impaired 7 7
Fistula 7 7
Sepsis 6 6
Vascular Dissection 5 5
Hematoma 4 4
Not Applicable 4 4
Thrombosis/Thrombus 4 4
Encephalopathy 4 4
Bacterial Infection 3 3
Multiple Organ Failure 3 3
Numbness 3 3
Renal Failure 3 3
Great Vessel Perforation 2 2
Cramp(s) 2 2
Rupture 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Extravasation 2 2
Cardiac Arrest 2 2
Stroke/CVA 2 2
Seroma 2 2
Skin Discoloration 2 2
Hepatitis 2 2
Swelling/ Edema 2 2
Insufficient Information 1 1
Low Blood Pressure/ Hypotension 1 1
Necrosis 1 1
Gangrene 1 1
Headache 1 1
Hemorrhage, Cerebral 1 1
Swelling 1 1
Tachycardia 1 1
Phlebitis 1 1
Reocclusion 1 1
Device Overstimulation of Tissue 1 1
Infarction, Cerebral 1 1
Edema 1 1
Fever 1 1
Calcium Deposits/Calcification 1 1
Atherosclerosis 1 1
Intimal Dissection 1 1
Radiation Overdose 1 1
Abdominal Pain 1 1
Abscess 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Ascites 1 1
Staphylococcus Aureus 1 1
Transient Ischemic Attack 1 1
Fungal Infection 1 1
Complaint, Ill-Defined 1 1
Confusion/ Disorientation 1 1
Lethargy 1 1
Paraplegia 1 1
Respiratory Failure 1 1

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