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

Catalog Number	DSF2233
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.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.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: on (b)(6) 2026, the patient underwent endovascular treatment of a thoracic arch aortic aneurysm using a gore® tag® conformable thoracic stent graft with active control system and a non-gore stent graft (najuta).It was reported that the access vessel was narrow.A 22fr gore® dryseal flex introducer sheath was inserted from the right side and was advanced approximately 5 cm from the insertion site.The gore® tag® conformable thoracic stent graft with active control system was attempted to be delivered but caught on the right external iliac artery.The 22fr sheath was gradually coming out; therefore, it was reinserted and advanced approximately 5 cm further than before, and the gore® tag® conformable thoracic stent graft with active control system was advanced again.The gore® tag® conformable thoracic stent graft with active control system was advanced to the intended position and deployed successfully.When the 22fr sheath was removed, it was observed that the blood pressure gradually decreased.When the delivery system of najuta was inserted, the blood pressure became stable.Therefore, the procedure was continued.After najuta was deployed proximally as planned and the delivery system of najuta was removed, angiography revealed a rupture of the right external iliac artery.A gore® viabahn® endoprosthesis with heparin bioactive surface was implanted to treat the rupture site.The physician stated that the access vessel was narrow.The diameter of the right external iliac artery was approximately 6.1 mm to 7.2 mm.It was reported that the rupture of the right external iliac artery may also have occurred when the gore® tag® conformable thoracic stent graft with active control system caught on the right external iliac artery.

• 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: asami aizawa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25687943
• Report Number: 3007284313-2026-04897
• Device Sequence Number: 17304671
• Product Code: DYB
• UDI-Device Identifier: 00733132630073
• UDI-Public: (01)00733132630073(17)290103
• 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): 07/02/2026

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: DSF2233
• 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: 06/15/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female