W. L. GORE & ASSOCIATES, INC. GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
|
Back to Search Results |
|
Device Problem
Peeled/Delaminated (1454)
|
Patient Problem
Vascular Dissection (3160)
|
Event Date 12/21/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
The item number and lot number of the device could not be provided, so no manufacturing evaluation could not be performed.The device remains implanted.As no identity or sufficient images of the device were provided for evaluation, the reported issue of this literature could not be confirmed.Citation: xi zhang, bo hu, yong xu, qiquan lai, et al.1 ¿6 © the author(s) 2022 article reuse guidelines: sagepub.Com/journals-permissions doi: 10.1177/11297298221074455journals.Sagepub.Com/home/jva.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
|
|
Event Description
|
The following information was received through literature ¿delamination and dissection of arteriovenous grafts: a multicenter report of four cases¿ published by the journal of vascular access 1¿6.The study was to report four cases of av graft dysfunction and failure rarely caused by graft delamination and dissection.Acuseal graft (6mm, w.L.Gore & associates, flagstaff, az, usa) was implanted.Graft delamination and dissection should be considered as a possible cause for av graft dysfunction and failure.Stenting and graft replacement may be recommended to treat av graft dissection and delamination.Case report 4: a (b)(6) female was diagnosed with end-stage renal disease.Eight months ago, a radial-basilic straight acuseal graft (6mm) was implanted across the elbow joint in the right arm since the av fistula access failed.The av graft was used for hemodialysis 48h after implantation.The patient did not receive anti-platelet or anti-coagulation medications.One month ago, the venous pressure started to increase during hemodialysis.One day prior to admission, the thrill over the av graft disappeared.Ultrasound examination found graft thrombosis with a dissection and delamination in the graft segment above the elbow joint (figure 4(a)).A procedure was performed to remove the dissected graft segment.Dark color indicated dissection of the posterior wall of the acuseal graft (figure 4(b)).The dissected segment of the acuseal graft was removed.Dissection of the posterior graft wall was confirmed, and stagnant blood was found in the false lumen (figure 4(c) and (d)).A stretch vascular graft (w.L.Gore & associates, flagstaff, az, usa) was used to connect the remaining segment of the acuseal graft and the basilic vein (figure 4(e)).At 1month follow-up, ultrasound examination showed no dissection or delamination in the grafts and no stenosis at the anastomosis of the two grafts (figure 4(f)).
|
|
Manufacturer Narrative
|
Add c1 and g3.
|
|
Search Alerts/Recalls
|
|
|