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

Device Problem Material Separation (1562)

Patient Problems Occlusion (1984); Pseudoaneurysm (2605)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During a discussion held at (b)(6), a physician revealed information regarding an experience he had with the gore® acuseal vascular graft.He stated the graft had developed multiple pseudoaneurysms and, during surgical intervention to treat these pseudoaneurysm, graft disintegration was reportedly observed.On (b)(6) 2017 a patient underwent a left brachial axillary arteriovenous graft access procedure using a gore® acuseal vascular graft.On an unknown date the patient presented with a thrombosed av graft which was unsuccessfully addressed by percutaneous thrombectomy by an outside provider.On (b)(6) 2017 the patient underwent an open thrombectomy.Multiple graft pseudoaneurysms were noted.The graft was explanted and the pseudoaneurysmal areas were repaired, mostly with sutures.Reportedly, the inner ptfe and elastomeric layers of the non-aneurysmal site appeared to have broken down in multiple places and does not look like a 3 month old graft.

Manufacturer Narrative

Updated to reflect an approximate date the pseudoaneurysms were recognized.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7144287
• MDR Text Key: 95719518
• Report Number: 2017233-2017-00637
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

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: Not provided
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2018
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 121