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 02/23/2022

Event Type  malfunction  

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 1: a (b)(6) female with end-stage renal disease had been on hemodialysis using a radial-cephalic fistula in the right arm and a brachial-cephalic fistula in the left arm for 3.5years.Eight months ago, a brachial-cephalic loop acuseal graft (6mm, w.L.Gore & associates, flagstaff, az, usa) was implanted in the left forearm below the elbow joint.The av graft was never punctured or canalized for hemodialysis.The patient was not on anti-platelet or anti-coagulation medications.At 1-month postoperative visit, ultrasound examination detected delamination and dissection in the graft segment below the elbow joint located 5cm away from the venous anastomosis (figure 1(a)).The delamination resulted in a luminal narrowing with the luminal diameter of 1.7mm and a filling defect shown in color doppler ultrasonography (figure 1(b)).The delamination and dissection were untreated and left for regular follow-up surveillance.Five months later, the av graft delamination and dissection disappeared (figure 1(c)) and the graft blood flow restored spontaneously (figure 1(d)).

Manufacturer Narrative

Update c1.

• 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: 13838683
• MDR Text Key: 293178344
• Report Number: 2017233-2022-02815
• 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: 02/24/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 02/24/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Female