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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)
2019 2020 2021 2022 2023 2024
13 12 12 8 9 2

MDR Year MDR Reports MDR Events
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
Misfire 546 546
Positioning Failure 432 432
Fracture 290 290
Break 220 220
Adverse Event Without Identified Device or Use Problem 157 157
Obstruction of Flow 105 105
Detachment of Device or Device Component 94 94
Material Perforation 85 85
Activation Failure 84 84
Material Deformation 78 78
Loss of or Failure to Bond 72 72
Difficult to Remove 55 55
Complete Blockage 50 50
Malposition of Device 49 49
Difficult or Delayed Positioning 45 45
Retraction Problem 43 43
Insufficient Information 36 36
Patient-Device Incompatibility 33 33
Positioning Problem 27 27
Difficult to Advance 22 22
Device-Device Incompatibility 19 19
Difficult or Delayed Activation 19 19
Migration or Expulsion of Device 17 17
Entrapment of Device 17 17
Material Separation 16 16
Separation Failure 15 15
Improper or Incorrect Procedure or Method 15 15
Failure to Advance 14 14
Migration 13 13
Premature Activation 13 13
Partial Blockage 11 11
Activation Problem 11 11
Device Dislodged or Dislocated 10 10
Activation, Positioning or Separation Problem 10 10
Failure to Unfold or Unwrap 9 9
Material Invagination 8 8
Material Split, Cut or Torn 8 8
Packaging Problem 7 7
Material Twisted/Bent 6 6
Device Markings/Labelling Problem 6 6
Off-Label Use 6 6
Microbial Contamination of Device 5 5
Mechanical Problem 5 5
Appropriate Term/Code Not Available 5 5
Patient Device Interaction Problem 4 4
Deformation Due to Compressive Stress 4 4
Difficult or Delayed Separation 4 4
Device Stenosis 4 4
Self-Activation or Keying 3 3
Device Damaged Prior to Use 2 2
Material Puncture/Hole 2 2
Material Rupture 2 2
Contamination /Decontamination Problem 2 2
Device Damaged by Another Device 2 2
Tear, Rip or Hole in Device Packaging 2 2
Physical Resistance/Sticking 2 2
Unintended Movement 2 2
No Apparent Adverse Event 2 2
Material Integrity Problem 2 2
Inaccurate Information 2 2
Missing Information 2 2
Separation Problem 2 2
Premature Separation 1 1
Difficult to Open or Close 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Structural Problem 1 1
Failure to Reset 1 1
Device Difficult to Setup or Prepare 1 1
Defective Component 1 1
Component Missing 1 1
Device Contamination with Body Fluid 1 1
Stretched 1 1
Unexpected Therapeutic Results 1 1
Poor Quality Image 1 1
Unsealed Device Packaging 1 1
Leak/Splash 1 1
Labelling, Instructions for Use or Training Problem 1 1
Collapse 1 1
Material Erosion 1 1
Fluid/Blood Leak 1 1
Flushing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 638 638
No Consequences Or Impact To Patient 329 329
Occlusion 90 90
Restenosis 78 78
Stenosis 74 74
No Known Impact Or Consequence To Patient 40 40
Aneurysm 36 36
No Code Available 33 33
Obstruction/Occlusion 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Thrombosis 23 23
Pain 22 22
Thrombosis/Thrombus 20 20
Injury 18 18
Pseudoaneurysm 18 18
Unspecified Infection 16 16
Hemorrhage/Bleeding 13 13
Death 12 12
Foreign Body In Patient 12 12
Thrombus 12 12
Perforation of Vessels 12 12
No Information 11 11
Ischemia 10 10
Blood Loss 9 9
Embolism 8 8
Fistula 7 7
No Patient Involvement 7 7
Insufficient Information 7 7
Perforation 6 6
Hematoma 5 5
Thromboembolism 5 5
Vascular Dissection 5 5
Device Embedded In Tissue or Plaque 5 5
Unspecified Tissue Injury 5 5
Swelling/ Edema 4 4
Claudication 4 4
Sepsis 4 4
Encephalopathy 4 4
Extravasation 3 3
Device Overstimulation of Tissue 3 3
Seroma 2 2
Skin Erosion 2 2
Hepatitis 2 2
Bacterial Infection 2 2
Not Applicable 2 2
Embolism/Embolus 2 2
Renal Failure 2 2
Numbness 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Skin Infection 1 1
Renal Impairment 1 1
Implant Pain 1 1
Fungal Infection 1 1
Paraplegia 1 1
Respiratory Failure 1 1
Complaint, Ill-Defined 1 1
Rupture 1 1
Staphylococcus Aureus 1 1
Great Vessel Perforation 1 1
Transient Ischemic Attack 1 1
Urinary Tract Infection 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Confusion/ Disorientation 1 1
Lethargy 1 1
Ascites 1 1
Calcium Deposits/Calcification 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1
Atherosclerosis 1 1
Wound Dehiscence 1 1
Abdominal Pain 1 1
Abscess 1 1
Fever 1 1
Gangrene 1 1
Edema 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Reocclusion 1 1
Swelling 1 1
Phlebitis 1 1

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