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	07/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, a patient was treated for a thoracoabdominal aortic aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) system.Gore® dryseal flex introducer sheath (gdsf) devices were used to gain access during the procedure.The right-side access was gained through a cut-down procedure.Because the right external iliac artery (reia) was small, a percutaneous transluminal angioplasty [pta] was performed in the reia.A gdsf2233 was then introduced on the right side for introduction of the tambe aortic component.All devices were deployed successfully.On (b)(6) 2025, 3 hours after the index procedure, the patient was treated for compartment syndrome related to the ipsilateral (right) femoral artery.Treatment was listed as "right leg fasciotomy wash out and medical fasciotomy incision closure." on (b)(6) 2025, the patient underwent a right lower extremity fasciotomy wound exploration, lateral open and durable negative wound vacuum-assisted closure application.The patient remains hospitalized.According to the physician, the cause of the compartment syndrome was likely due to occlusive sheath.The sheath occluded collateral flow from internal iliac artery; and due to the small iliac arteries, there was minimal flow to the right lower extremity for approximately 6-8 hours.
Additional Manufacturer Narrative
H.6.Type of investigation code b18: the device was discarded at the treating facility and was therefore not available for analysis.H.6.Investigation findings code c19: the device history record was reviewed to ensure that each manufacturing and inspection operation was performed and indicated the product met creganna medical specifications and procedures.Updated h.6.Type of investigation from b21 to b13, b14, b18.Updated h.6.Investigation findings from c21 to c19, c20.Updated h.6.Investigation conclusions from d16 to d1002, d12.

• 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: 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22854609
• Report Number: 3007284313-2025-04201
• Device Sequence Number: 19955278
• Product Code: DYB
• UDI-Device Identifier: 00733132659012
• UDI-Public: (01)00733132659012(17)270924
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/27/2025

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: 07/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2024
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 87 KG