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

Device Problem Device Stenosis (4066)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/29/2022

Event Type  Injury  

Event Description

The following information was provided to gore: on september 29, 2022, a comment was gathered in the course of market research.Reportedly, this was from a qualitative market research study conducted on behalf w.L gore & associates.Question - "what unanticipated issues have you identified using the gore-tex® vascular grafts configured for pediatric shunt?" physician gave this response - "thrombosis".

Manufacturer Narrative

Cause of the reported event cannot be established based on the incoming information.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.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.

• Brand Name: GORE-TEX® 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15634122
• MDR Text Key: 302025577
• Report Number: 2017233-2022-03416
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 10/19/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other