Abstract: TH-PO294
FDA Reported Complications Associated With endoAVF Fistula Devices
Session Information
- Vascular Access: From Biology to Managing Complications
November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 703 Dialysis: Vascular Access
Authors
- Abraham, Rahul R., LSU Health Shreveport, Shreveport, Louisiana, United States
- Mayeux, Erin L., LSU Health Shreveport, Shreveport, Louisiana, United States
- Adisa, Oluwadamilola, LSU Health Shreveport, Shreveport, Louisiana, United States
- Baker, Atlee, LSU Health Shreveport, Shreveport, Louisiana, United States
- Mccutchan, Braeden, LSU Health Shreveport, Shreveport, Louisiana, United States
- Okuampa, David, LSU Health Shreveport, Shreveport, Louisiana, United States
- Gould, Haley E., LSU Health Shreveport, Shreveport, Louisiana, United States
- Blochousse, Marjorie, LSU Health Shreveport, Shreveport, Louisiana, United States
- Sachdeva, Bharat, LSU Health Shreveport, Shreveport, Louisiana, United States
Background
Medical device reports (MDRs) are submitted to U.S. Food and Drug Administration (FDA) for all suspected device-associated injuries and deaths. The Manufacturer and User Facility Device Experience (MAUDE) database compiles all MDRs to monitor device outcomes. We review all reported MDRs for WavelinQ® (Bard Peripherals) and the Ellipsys® (Medtronic) used for percutaneous creation of dialysis AVF.
Methods
All reported incidents of all endoAVF devices to the FDA database from August 2018-March 2022 were imported to excel, and descriptive statistical analysis was carried out.
Results
Events were divided into device-related when the incident involved mechanical device malfunction and patient-related if the subject experienced a complication during endoAVF creation. There were 200 events reported for Wavelinq® over 3.12 years, with a rate of 65 events/year. 81% of total events were device-related issues, with the most common reports of failure to cut (41%), material deformations (28%), and failure of magnets to align (23%) during the AVF creation. 19% were patient-related, including, vessel stenosis (35%), vessel spasm (14%), Ischemic neuropathy (11%), and death (8%). Ten events (5%) were reported with the 6F system, and all others were related to the 4F system.
Eleven events were reported for Ellipsys® over a period of 2.03 years, with a rate of 5.41 events reported per year (3.44 device-related and 1.97 patient-related); 36% of total events were device-related issues, with the most common problems being failure to advance (50%), inability to activate the device (25%) and material deformation (25%). Nearly two-thirds (64%) of events were patient-related complications, including thrombosis (57%), hematoma (29%), and stenosis of the vessel (14%).
Conclusion
Wavelinq® system had predominant device-related issues, while two-thirds of the Ellipsys® related events were patient-related. MAUDE database cannot calculate the actual incidence rate of events or make comparisons, as physicians voluntarily report the complications, and the prevalence of the use of these devices is unknown.
There is limited information available regarding post-market real-life experience on these two devices. Providers need to be aware of the commonly reported device and patient-related complications associated with endoAVF devices.