MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Fluid/Blood Leak (1250)

Patient Problems Aneurysm (1708); Seroma (2069)

Event Date 05/17/2023

Event Type  Injury  

Manufacturer Narrative

Device lot/serial information could not be obtained.Therefore, no manufacturing evaluation could be performed.The device was not returned to w.L.Gore & associates, inc.Consequently, a direct product analysis was not possible.According to gore-tex® stretch vascular graft instructions for use: the possible complications with the use of any vascular prosthesis: ultrafiltration or perigraft seroma, and formation of pseudoaneurysms.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 Description

The following was reported to gore: a gore-tex® stretch vascular graft (y graft) was implanted to treat an abdominal aortic aneurysm about 13 years ago.On (b)(6) 2023, a seroma occurred from a gore-tex® stretch vascular graft and this seroma formed an aneurysm which was about 100cm.The seroma was resected by open surgery and a stent graft was implanted in the y graft.

• Brand Name: GORE-TEX® STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• 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: amy mckeown ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16992709
• MDR Text Key: 315861369
• Report Number: 2017233-2023-03957
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K903931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• 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
• Date Manufacturer Received: 05/17/2023
• 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): Other
• Patient Age: 75 YR
• Patient Sex: Male