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

Catalog Number	ECH470045A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.A2; a4: patient information was requested, but not made available.H6 - code c21: review of device manufacturing record history is current underway.Results pending completion of investigation.H6 - code b20: device remains implanted and no images were provided.Therefore, direct product analysis was not possible.Ifu for gore® acuseal vascular graft state: complications which may occur in conjunction with the use of any vascular prosthesis and/or vascular or related procedures include but are not limited to: infection; partial or complete occlusion due to hemodynamically significant stenosis or thrombosis; w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
The following was reported to gore: a patient presented for an arteriovenous (a-v) access revision in the left upper arm.As reported, an a-v graft loop (gore® acuseal vascular graft) was implanted on (b)(6) 2025.Now the loop graft had clotted and required an open thrombectomy.Fistulagram on both arterial and venous anastomosis revealed significant stenosis to the venous outflow that required stenting.On (b)(6) 2025, an 8fr x 10cm brite tip sheath was used to advance the gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) to the intended treatment site.The viabahn device was placed and deployed fine.As the delivery catheter was withdrawn, the distal tip caught on the edge of the sheath.It was reported the distal tip came off.The physician was able to retrieve the distal tip along with the sheath removal.The patient did not experience any adverse consequences.
Additional Manufacturer Narrative
H6 - code c21: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code b20: device remains implanted and no images were provided.Therefore, direct product analysis was not possible.Ifu for gore® acuseal vascular graft state: complications which may occur in conjunction with the use of any vascular prosthesis and/or vascular or related procedures include but are not limited to: infection; partial or complete occlusion due to hemodynamically significant stenosis or thrombosis.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21589085
• Report Number: 2017233-2025-05929
• Device Sequence Number: 18400777
• Product Code: DSY
• UDI-Device Identifier: 00733132626984
• UDI-Public: (01)00733132626984(17)270518
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K130215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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 Catalogue Number: ECH470045A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Required Intervention
• Patient Sex: Male