MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER

Catalog Number	DSF1433
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2026, a patient underwent an endovascular procedure to treat an abdominal aortic aneurysm using a gore® excluder® conformable aaa endoprosthesis device, gore® excluder® aaa endoprosthesis system devices, and gore® dryseal flex introducer sheaths (16fr and 14fr).A 16fr sheath was inserted into the left external iliac artery (leia), and a trunk-ipsilateral leg was inserted through the leia.During deployment of the trunk-ipsilateral leg, it migrated distally; it was fully deployed in that position.The length of the migration was unknown.An aortic extender was deployed to extend the trunk-ipsilateral leg proximally.A 14fr sheath was inserted into the right external iliac artery (reia), and a contralateral leg device was inserted through the reia.Vascular access angiography revealed dissections in the right and left external iliac arteries.Stents were placed in the right and left external iliac arteries to treat the dissections.Reportedly, the minimum diameter of the patient's leia was 3.0 mm; it was smaller than the outer diameter of the 16fr sheath (6.0 mm).Also, the minimum diameter of the patient's reia was 2.6 mm; it was smaller than the outer diameter of the 14fr sheath (5.3 mm).The physician considered that the access vessels degenerated due to the patient's paraplegia.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: code d1101: this complaint includes information indicating the reported complications relate to use of a sheath size that was too large for the patient access vessel anatomy per the device instructions for use.The device instructions for use provide warning and instruction to ensure the vessel diameter is adequate to accommodate the device.Please note that the same patient was captured in medwatch report number 3007284313-2026-04814.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® DRYSEAL FLEX INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: mana yamamoto ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25326085
• Report Number: 3007284313-2026-04815
• Device Sequence Number: 13250358
• Product Code: DYB
• UDI-Device Identifier: 00733132630004
• UDI-Public: (01)00733132630004(17)270902
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: DSF1433
• 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: 05/15/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2025
• 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
• Patient Age: 73 YR
• Patient Sex: Male