MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

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.A (b)(6) male had been on chronic hemodialysis using a left radial-cephalic fistula and then a left brachial-cephalic fistula for a year.Three years ago, a brachial-basilic loop acuseal graft (6mm) was implanted across the elbow joint in the left arm for hemodialysis.Since then, the graft had been punctured for regular hemodialysis.The patient was not on anti-platelet or anti-coagulation therapy.Seven months ago, the time required for routine hemostasis was remarkably prolonged due to increased venous pressure.Ultrasound examination found dissection and delamination in the graft which was located in the upper arm and 5cm away from the venous anastomosis (figure 2(a)).The diameter of the graft was narrowed to 2.2mm with a significant filling defect (figure 2(b)).The delaminated and narrowed graft was dilated using a high-pressure balloon (6mm×40 mm, conquest, becton dickinson, franklin lakes, nj, usa), and a covered stent (viabahn endoprosthesis, 6mm×5cm, w.L.Gore & associates, flagstaff, az, usa) was placed.The graft narrowing was resolved by the stenting (figure 2(c)), and the blood flow was restored (figure 2(d)).

Manufacturer Narrative

Add c1 and g3.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• 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: 13858149
• MDR Text Key: 289101135
• Report Number: 2017233-2022-02817
• 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?: Yes
• Is this a Product Problem Report?: No
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male