MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number ECH060040J

Device Problems Complete Blockage (1094); Peeled/Delaminated (1454)

Patient Problems Hematoma (1884); Obstruction/Occlusion (2422)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following was reported to gore: on an unknown date in (b)(6) 2017, the patient underwent a shunt construction procedure (the right radial artery to basilic vein) for dialysis utilizing a gore® acuseal vascular graft.On (b)(6) 2021, a percutaneous transluminal angioplasty (pta) was performed in response to stenosis found near an anastomosis of a vein in the gore® acuseal vascular graft.On (b)(6) 2021, an occlusion of the gore® acuseal vascular graft was observed.An echo image revealed that there was a delamination in the cannulation site near the apex of the vascular loop, slightly towards the vein.Additionally, a hematoma was observed between the layers.Reportedly, this delamination and the stenosis confirmed on (b)(6) 2021 were in different areas.On (b)(6) 2021, part of the gore® acuseal vascular graft containing the delamination was removed and a gore® viabahn® endoprosthesis with propaten bioactive surface was used as an extension.The physician stated that the delamination was confirmed in the cannulation site.He suggested that the needle might have been inserted between layers of the gore® acuseal vascular graft because the cannulation angle was shallow.

Manufacturer Narrative

The device was not returned, but device pictures were provided for analysis: the identity of the device was provided; no abnormalities were found in the associated device history record.The evaluation found no anomalies attributable to the manufacture of the device.

• 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
• MDR Report Key: 12293876
• MDR Text Key: 265586154
• Report Number: 2017233-2021-02222
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2019
• Device Catalogue Number: ECH060040J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 68 YR