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

Catalog Number ECH060040J

Device Problem Peeled/Delaminated (1454)

Patient Problem Renal Failure (2041)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records could not be completed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.The event date, (b)(6) 2019, is an estimate based on the available information.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.

Event Description

The following information was reported to gore: on an unknown date, the patient underwent a shunt procedure to renal failure using gore® acuseal® vascular graft.On an unknown date in early (b)(6) 2019, the patient underwent thrombectomy (fogarty) in the gore® acuseal® vascular graft.When the physician cut the acuseal near the vein anastomosis, with a scalpel, it seemed that there was a space between the silicon layer and the outer layer of acuseal.The doctor alleged the gore® acuseal® vascular graft appeared to be delaminated.The range of delamination was about 1 cm from the cut to the left and right.The thrombectomy was completed without issues.The patient tolerated the procedure.

Manufacturer Narrative

Additional manufacturer narrative: a1: patient identifier.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8732985
• MDR Text Key: 149211042
• Report Number: 2017233-2019-00459
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECH060040J
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other