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

Catalog Number SGS-183L

Device Problem Device Stenosis (4066)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/15/2023

Event Type  Injury  

Manufacturer Narrative

Information was obtained through a publication.Author was unable to provide any further details to aid in further investigation.No lot number information was supplied; therefore, no review of the manufacturing records could be reviewed.The device(s) were not returned and no images were provided.Therefore, direct product analysis was not possible.Instructions for use for gore-tex® stretch vascular graft possible complications with the use of any vascular prosthesis complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: 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 Description

Title: a case report, successful treatment for extracardiac conduit thrombus in patient after fontan completion source: j.Cardiovasc.Surg.52: 449-451 (2023) the report is about a case of thrombus in extracardiac conduit leading to liver damage after the fontan completion.The patient was an 11-year-old girl, who underwent the fontan procedure at 3 years of age using a 18mm gore-tex® stretch vascular graft.She was on aspirin for thromboprophylaxis.Eight years postoperatively (at 11 years of age), cardiac catheterization and ct demonstrated severe conduit stenosis (thrombus with calcification), and chronic liver damage was seen at that time.The patient successfully underwent conduit replacement whereby a new conduit (vascular graft) was reanastomosed, leaving 5 mm of both ends of the gore-tex® stretch vascular graft.Subsequently, ascites disappeared and platelet count improved.Postoperatively, combination therapy with aspirin and warfarin was initiated for thromboembolic prophylaxis and is ongoing.

• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18735917
• MDR Text Key: 335812941
• Report Number: 2017233-2024-04632
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: SGS-183L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 11 YR
• Patient Sex: Female
• Patient Weight: 25 KG