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

Catalog Number	DSF1633
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/01/2026
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.The reported information indicates the patient's left external iliac artery had diameters ranging 8.4mm to 9.6mm which are larger than the nominal diameter of the dsf1633 dryseal sheath (6.1mm); however, the access vessel was also strongly calcified.The device instructions for use (ifu) provide warning to evaluate the vessel for calcification to ensure successful device use.The ifu also warn against continuing to advance the device if there is resistance; instead, the source of resistance should be identified before proceeding to avoid vessel damage and/or device breakage.The cause of the reported insertion resistance may be attributed to use of the device in a calcified vessel as reported.Vessel dissection is a known adverse event that can occur when using the device, but the cause for the reported left external iliac artery dissection is likely related to continued advancement of the device when resistance was encountered.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 an abdominal aortic aneurysm using a gore® excluder® conformable aaa endoprosthesis, gore® excluder® aaa endoprosthesis devices and gore® dryseal flex introducer sheath devices.After all devices were implanted, angiography revealed a localized dissection in the left external iliac artery.A stent was implanted to cover the dissection.The patient tolerated the procedure.The physician stated that there was resistance during insertion of the 16fr gore® dryseal flex introducer sheath.It was reported that there was strong calcification in the access vessel.The diameter of the left external iliac artery was about 8.4 ¿ 9.6 mm.

• 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: 25267292
• Report Number: 3007284313-2026-04800
• Device Sequence Number: 9157562
• Product Code: DYB
• UDI-Device Identifier: 00733132630028
• UDI-Public: (01)00733132630028(17)280908
• 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): 05/25/2026

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: DSF1633
• 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: 05/01/2026
• Initial Report FDA Received Date: 05/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2025
• 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: 80 YR
• Patient Sex: Male