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.
| Device Type ID | 1079 |
| Device Name | System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment |
| Physical State | The Endovascular Stent-graft Is A Metal Scaffold Covered With Fabric Material. The Stent-graft Is Placed Via A Delivery Catheter Into The Arteriovenous Dialysis Access Circuit To Maintain Or Re-establish Vessel Patency For Hemodialysis. The Endovascu |
| Technical Method | Generally, A Peripheral Transluminal Angioplasty (PTA) Catheter Is Used Initially To Open Up The Occlusion And Allow For Passage Of The Endovascular Graft Delivery System To Pass Through. The Endovascular Graft Is Then Deployed At The Site Of The Occ |
| Target Area | Stenotic Lesions Or Thrombotic Occlusions In The Arteriovenous Dialysis Access Circuit, Including The Venous Anastomosis. |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PFV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1079 |
| Device | System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment |
| Product Code | PFV |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Positioning Failure | 260 |
Fracture | 187 |
Misfire | 150 |
Break | 65 |
Material Perforation | 57 |
Detachment Of Device Or Device Component | 39 |
Malposition Of Device | 23 |
Difficult To Remove | 20 |
Activation Failure Including Expansion Failures | 18 |
Activation, Positioning Or Separation Problem | 18 |
Material Deformation | 18 |
Difficult To Advance | 14 |
Positioning Problem | 13 |
Obstruction Of Flow | 13 |
Adverse Event Without Identified Device Or Use Problem | 13 |
Difficult Or Delayed Positioning | 12 |
Material Invagination | 12 |
Failure To Advance | 12 |
Stent | 11 |
Premature Activation | 11 |
Complete Blockage | 10 |
Retraction Problem | 9 |
Occlusion Within Device | 8 |
Material Separation | 8 |
Entrapment Of Device | 7 |
Migration Or Expulsion Of Device | 7 |
Appropriate Term/Code Not Available | 6 |
Insufficient Information | 6 |
Device-Device Incompatibility | 6 |
Separation Failure | 5 |
Bent | 5 |
Patient-Device Incompatibility | 5 |
Improper Or Incorrect Procedure Or Method | 4 |
Device Operates Differently Than Expected | 3 |
Use Of Device Problem | 3 |
Device Damaged By Another Device | 3 |
Material Fragmentation | 3 |
Hole In Material | 3 |
Off-Label Use | 3 |
Partial Blockage | 3 |
Leak / Splash | 2 |
Patient Device Interaction Problem | 2 |
Failure To Unfold Or Unwrap | 2 |
Difficult Or Delayed Activation | 2 |
Difficult To Insert | 2 |
Kinked | 2 |
Material Rupture | 2 |
Deformation Due To Compressive Stress | 2 |
Material Puncture / Hole | 2 |
Difficult To Open Or Close | 2 |
Material Twisted / Bent | 2 |
Device Contamination With Body Fluid | 2 |
Migration | 1 |
Tip | 1 |
Material Split, Cut Or Torn | 1 |
Activation Problem | 1 |
Device Difficult To Setup Or Prepare | 1 |
Shaft | 1 |
Device Damaged Prior To Use | 1 |
Disconnection | 1 |
Material Erosion | 1 |
Premature Separation | 1 |
Device Markings / Labelling Problem | 1 |
Stretched | 1 |
Mechanical Problem | 1 |
Nonstandard Device | 1 |
Packaging Problem | 1 |
Split | 1 |
Out-Of-Box Failure | 1 |
Physical Resistance / Sticking | 1 |
| Total Device Problems | 1115 |