MAUDE Adverse Event Report: W. L. Gore & Associates, Inc. GORE® DrySeal Flex Introducer Sheath; Introducer, Catheter

Catalog Number	GDSF2233
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was received from clinical complaint specialist: on (b)(6)2026, the patient underwent endovascular procedure to treat a pararenal aneurysm at the descending thoracic aorta using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) device system.A gore® dryseal flex sheath (dsf) was used for access.During the procedure, compartment syndrome of the left leg occurred.Left leg angiogram and fasciotomy occurred.This is reportedly attributed to the use of the dsf.This event is listed as ongoing.The procedure lasted about 5 hours and 15 minutes.Reportedly, the left external iliac artery measured 10mm.
Additional Manufacturer Narrative
H.6.Investigation findings code c21: conclusions pending results of product history review 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; +1(928)526-3030
• MDR Report Key: 50176142
• Report Number: 3007284313-2026-04997
• Device Sequence Number: 8263221
• Product Code: DYB
• UDI-Device Identifier: 00733132659012
• UDI-Public: (01)00733132659012(17)280115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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
• Device Catalogue Number: GDSF2233
• 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: 07/15/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 248 LB
• Patient Race: White