MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Thrombosis/Thrombus (4440)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Cbas® heparin surface incorporates cbas-heparin manufactured from (b)(4), which is covalently bound to the device surface and is essentially non-eluting.Citation: the journal of vascular access 1¿8.The author(s) 2020 article reuse guidelines: sagepub.Com/journals-permissions.Doi: 10.1177/1129729820961955.Journals.Sagepub.Com/home/jva.

Event Description

The following information was received through literature ¿use of the viabahn covered stent for the treatment of venous rupture during interventions of dysfunctional or thrombosed hemodialysis vascular access¿ published by the journal of vascular access 1¿8.The study was to report the immediate outcomes and patency rates of a covered stent to rescue angioplasty-related venous rupture of hemodialysis vascular access.A total of 52 vessel ruptures (21 fistulas, 31 grafts) salvaged by using viabahn covered stents were enrolled from january 2013 to december 2018.The results state that in one patient, the bleeding was successfully stopped, but the procedure was ultimately unsuccessful due to a large thrombus burden.Anatomical success of the pta procedure was defined as <30% residual stenosis at the stent area.In another patient, the procedure was successful; however, recurrent thrombosis developed before the dialysis session.One patient had vascular access infection within 1 month after the procedure, and the av graft was removed.

Manufacturer Narrative

Update g4.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12369066
• MDR Text Key: 268245742
• Report Number: 2017233-2021-02309
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• Reporter Country Code: TW
• PMA/PMN Number: P130006
• 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: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• 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
• Date Manufacturer Received: 08/14/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female