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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)
2020 2021 2022 2023 2024 2025
12 12 8 9 5 7

MDR Year MDR Reports MDR Events
2020 337 337
2021 281 281
2022 261 261
2023 229 229
2024 212 212
2025 82 82

Device Problems MDRs with this Device Problem Events in those MDRs
Misfire 543 543
Positioning Failure 436 436
Fracture 286 286
Break 233 233
Adverse Event Without Identified Device or Use Problem 164 164
Material Deformation 103 103
Activation Failure 92 92
Detachment of Device or Device Component 90 90
Loss of or Failure to Bond 75 75
Material Perforation 73 73
Obstruction of Flow 70 70
Malposition of Device 50 50
Difficult or Delayed Positioning 40 40
Difficult to Remove 37 37
Retraction Problem 33 33
Insufficient Information 26 26
Positioning Problem 26 26
Patient-Device Incompatibility 21 21
Difficult to Advance 20 20
Complete Blockage 18 18
Migration or Expulsion of Device 17 17
Material Separation 17 17
Device-Device Incompatibility 15 15
Failure to Advance 15 15
Entrapment of Device 14 14
Packaging Problem 12 12
Activation Problem 11 11
Difficult or Delayed Activation 10 10
Migration 10 10
Premature Activation 10 10
Material Twisted/Bent 8 8
Improper or Incorrect Procedure or Method 8 8
Separation Failure 7 7
Material Invagination 7 7
Device Stenosis 6 6
Device Markings/Labelling Problem 6 6
Physical Resistance/Sticking 6 6
Partial Blockage 5 5
Off-Label Use 5 5
Device Dislodged or Dislocated 5 5
Deformation Due to Compressive Stress 5 5
Device Contamination with Chemical or Other Material 4 4
Microbial Contamination of Device 4 4
Appropriate Term/Code Not Available 4 4
Failure to Unfold or Unwrap 3 3
Difficult or Delayed Separation 3 3
Material Rupture 3 3
Material Fragmentation 3 3
Material Puncture/Hole 3 3
Material Split, Cut or Torn 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 845 845
No Consequences Or Impact To Patient 163 163
Restenosis 99 99
Stenosis 47 47
Occlusion 36 36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 32 32
Obstruction/Occlusion 31 31
Aneurysm 28 28
Thrombosis/Thrombus 27 27
No Code Available 21 21
Pain 20 20
No Known Impact Or Consequence To Patient 18 18
Foreign Body In Patient 13 13
Insufficient Information 12 12
Perforation of Vessels 10 10
Injury 9 9
Thrombosis 9 9
Hemorrhage/Bleeding 8 8
Ischemia 8 8
Unspecified Infection 7 7
Death 6 6
Perforation 6 6
Bacterial Infection 5 5
Hematoma 5 5
Pseudoaneurysm 5 5
Swelling/ Edema 5 5
Unspecified Tissue Injury 5 5
Fistula 4 4
Vascular Dissection 4 4
No Patient Involvement 4 4
Failure of Implant 3 3
Blood Loss 3 3
Extravasation 3 3
Device Overstimulation of Tissue 3 3
Skin Erosion 3 3
Device Embedded In Tissue or Plaque 2 2
Thrombus 2 2
Thromboembolism 2 2
Renal Impairment 2 2
Numbness 2 2
Seroma 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Embolism/Embolus 2 2
Sepsis 2 2
Hypersensitivity/Allergic reaction 2 2
Claudication 1 1
Abscess 1 1
Anemia 1 1
Rupture 1 1
Renal Failure 1 1

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