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

Model Number	ECH460045A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Blood Loss (2597)
Date of Event	01/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The following was reported to gore: the patient received a fistula for av access at the university hospital of (b)(6) and is sent home to (b)(6) for dialysis at fresenius kidney care.After approximately 2 weeks of dialysis with the fistula, the patient returns to university hospital of (b)(6), as the fistula has become non-functional (unable to be used for dialysis).The fistula is abandoned and the surgeon who created the fistula, implants a gore® acuseal vascular graft on (b)(6) 2020 in the upper arm.The patient returns to hazard, kentucky for dialysis.Patient presented at fresenius kidney care ((b)(6)) for dialysis (b)(6) 2020 (2 days post implant).Two 17 gauge dialysis needles are used to access inflow and outflow of the acuseal graft and the dialysis machine is adjusted to 100ml per minute for the initial time period on dialysis.During the dialysis session the patient complained about arm pain and swelling/hematoma was observed.The patient was sent to (b)(6) medical center er with the two dialysis needles still in the arm.Fasciotomy is performed to control bleeding and to treat compartment syndrome.The er surgeon reported there were no visible problems associated with the gore® acuseal vascular graft and both venous and arterial anastomoses appeared intact.The two dialysis needle cannulation holes were observed on the anterior aspect of the graft.Er surgeon placed a stay-suture on one of the cannulation needle holes of the acuseal graft.On (b)(6) 2020 the later patient returns to university hospital of (b)(6) where a fistula gram is performed by the implanting surgeon.During the procedure the surgeon observed that the gore® acuseal vascular graft was functioning as intended, no outflow stenosis was observed, and that a suture had been placed on one of the needle holes of the graft.The patient is currently recovering and dialyzing through a catheter until the surgeon decides when to initiate cannulation through the acuseal graft.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9618623
• Report Number: 2017233-2020-00048
• Device Sequence Number: 2738965
• Product Code: DSY
• UDI-Device Identifier: 00733132634811
• UDI-Public: 00733132634811
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K130215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/07/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2022
• Device Model Number: ECH460045A
• Device Catalogue Number: ECH460045A
• Device Lot Number: 6535184PP002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention