MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Peeled/Delaminated (1454)

Patient Problem Vascular Dissection (3160)

Event Date 12/21/2021

Event Type  malfunction  

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 3: a (b)(6) male had been on chronic hemodialysis using a tunneled cuffed catheter implanted in the right internal jugular vein for 4years.Two years ago, a loop acuseal graft (6mm, inflow, superficial femoral artery; outflow, great saphenous vein) was implanted in the left lower extremity below the inguinal region for hemodialysis.Then, the graft had been punctured for regular hemodialysis.Since the procedure, the patient had been on oral aspirin (100mg/d) but not on anti-coagulation therapy.Eighteen months ago, the venous pressure was significantly increased during hemodialysis.Ultrasound examination detected a graft dissection and delamination located 3cm away from the venous anastomosis below the inguinal region (figure 3(a)).The luminal diameter was significantly decreased to 2.2mm.The physician punctured the false lumen of the dissected graft and withdrew 2.8ml blood.After the procedure, the graft dissection and delamination were partially resolved, and the luminal diameter was increased to 3.9mm (figure 3(b) and (c)).Since then, the graft continued to be used for hemodialysis without puncturing the dissected and delaminated segment.Eight months ago, ultrasound examination found multiple dissections with luminal thrombus formation in the graft (figure 3(d)).The dissected graft might be able to be rescued by implanting multiple covered stents, which could largely reduce the region for future punctures.Therefore, the graft was then abandoned.

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.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13866103
• MDR Text Key: 290549998
• Report Number: 2017233-2022-02819
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male