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

Catalog Number	DSF2433
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Vascular Dissection (3160)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient referenced in this event file is enrolled in the tgr23-02tb together aortic registry and information regarding this event was gathered from the imedidata rave clinical study database (csd).Gore has reached out to the study site for more information on the event and device identification, answers pending.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 from the imedidata study database: on (b)(6) 2025, during an index procedure of an aneurysm repair, a patient suffered a dissection of the right external iliac artery (eia) with acute ischemia, related to the use of a gore® dryseal flex introducer sheath.The patient underwent on (b)(6) 2025, resection of the common femoral artery and the right eia with retrograde stenting in the right eia.The patient recovered.
Additional Manufacturer Narrative
Updated d4.Updated d10: concomitant medical products: (relevant associated devices used with the device being reported on): gore® tag® thoracic branch endoprosthesis, gore® tag® conformable thoracic stent graft with active control system.Updated h4.Updated h6: added health effect - clinical code e0509.Replaced medical device problem code a24 with a0101.Added type of investigation code b14, b17, and b11.Updated investigation findings code to c19, code c21 is no longer applicable.Updated investigation conclusions code to d15 and d12, code d16 is no longer applicable.Gore reviewed the results of the review of the device history records performed by creganna for the reported lot number, which showed that the release criteria had been met.The device was not returned.Therefore, a device evaluation could not be performed.No pre-procedure imaging measurements were reported.No follow-up imaging reported.The sizing of the device in relation to the patients' anatomy in therefore unknown.The available information reported in the complaint does not reasonably suggest a potential malfunction or product packaging and/or labeling issue has occurred.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.The gore® dryseal flex introducer sheath instructions for use (ifu) list adverse events that may occur and / or require intervention include, but are not limited to: embolization (micro or macro) with transient or permanent ischemia, vascular trauma (i.E., dissection, rupture, perforation, tear, etc.).

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23546793
• Report Number: 3007284313-2025-04363
• Device Sequence Number: 15773956
• Product Code: DYB
• UDI-Device Identifier: 00733132630950
• UDI-Public: (01)00733132630950(17)280408
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/13/2026

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: DSF2433
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American