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

Catalog Number	DSF1245
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore on (b)(6) 2025 from the imedidata study database: on (b)(6) 2025, this 62-year-old male patient underwent endovascular treatment for an aortoiliac aneurysm.The patient was treated with a gore® excluder® aaa trunk ipsilateral leg endoprosthesis, gore® excluder® aaa endoprosthesis devices and gore® excluder® branch endoprosthesis devices.There was successful access, delivery and accurate deployment of the devices to the intended location and successful retrieval of the delivery systems.The patient was discharged home on (b)(6) 2025.It was reported that the patient had intraoperative bleeding related to treatment/procedure.This led to transfusion.
Additional Manufacturer Narrative
A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.As gore was unable to determine which device/device component is involved in this reportable adverse event, the following additional device will be identified in this report: catalog #dsf1633, serial #(b)(6), udi (b)(4) / catalog #dsf1633, serial #(b)(6), udi (b)(4).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.
Additional Manufacturer Narrative
Updated b5.
Event or Problem Description
The following was reported to gore from the imedidata study database: on (b)(6) 2025, this 62-year-old male patient underwent endovascular treatment for an aortoiliac aneurysm.The patient was treated with a gore® excluder® aaa trunk ipsilateral leg endoprosthesis, gore® excluder® aaa endoprosthesis devices and gore® excluder® branch endoprosthesis devices.There was successful access, delivery and accurate deployment of the devices to the intended location and successful retrieval of the delivery systems.It was reported that the patient had a bleeding at the left femoral artery access site related to treatment/procedure.This led to transfusion.The patient was discharged home on (b)(6) 2025.

• 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: 23814360
• Report Number: 3007284313-2025-04456
• Device Sequence Number: 21355312
• Product Code: DYB
• UDI-Device Identifier: 00733132628117
• UDI-Public: (01)00733132628117(17)261023
• 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,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: DSF1245
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2024
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 99 KG