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

Catalog Number	DSF1433
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to gore: on (b)(6) 2026, the patient underwent endovascular treatment of a right common iliac artery aneurysm using a non-gore stent graft (main device: afx), gore® excluder® aaa endoprosthesis devices, and gore® excluder® conformable aaa endoprosthesis devices.The non-gore stent graft was implanted in the abdominal aorta.An 18 fr gore® dryseal flex introducer sheath was then inserted from the right side, and three aortic extender endoprostheses (two gore® excluder® conformable aaa endoprostheses and one gore® excluder® aaa endoprosthesis) were implanted proximally.An iliac branch component was delivered from the right side and deployed.A 14 fr sheath was inserted alongside an 18 fr sheath, and the ipsilateral u turn technique was performed.Although the u turn was achieved, there was strong resistance and the iliac branch component migrated distally.Digital subtraction angiography (dsa) confirmed that the gate of the iliac branch component was not compressed at that time.Cannulation of the internal iliac artery was attempted using a radifocus wire and a kmp catheter, and the internal iliac artery was dilated using a pta balloon.The wire was then exchanged for an ass wire, and delivery of an internal iliac component was attempted, but it could not be advanced.Because the 14 fr sheath could not be advanced and the guidewire slipped out, it was decided to reattempt cannulation.While removing the 14 fr sheath and the catheter of the internal iliac component over the ass wire, the 14 fr sheath fractured; the sheath coil protruded and became entangled with the internal iliac component, resulting in damage to that component.The constrained stent graft migrated toward the leading olive, and the deployment line running through the catheter broke.The entire 14 fr sheath was removed from the patient.The sheath valve of the 18fr sheath was also damaged.A 20 fr gore® dryseal flex introducer sheath was inserted, and the u turn technique was attempted using a 16 fr gore® dryseal flex introducer sheath.The 20 fr sheath was inserted, but there was strong resistance and further advancement was difficult.After the 20 fr sheath was temporarily removed for confirmation, the right common femoral artery tore/ruptured.The right common femoral artery was reconstructed using a gore® propaten® vascular graft.Subsequently, a 16 fr dryseal flex introducer sheath was inserted, and the u turn technique was attempted through a 12 fr dryseal flex introducer sheath.A radifocus wire, a kmp catheter, and a jr catheter were used to cannulate the internal iliac artery, but this remained difficult; several further attempts were made, but cannulation could not be achieved.During these attempts, the iliac branch component gradually migrated distally and the gate became compressed.Cannulation was abandoned.To obstruct flow to the right internal iliac artery, plugs were implanted in the right internal iliac artery and within the right common iliac artery aneurysm.An iliac extender endoprosthesis was implanted beginning within the iliac branch component and extending to approximately 3 cm proximal to it, and an aortic extender endoprosthesis (gore® excluder® conformable aaa endoprosthesis) was implanted slightly proximal to the iliac extender endoprosthesis.Dsa revealed a type iii endoleak from the overlap between the non-gore stent graft and the gore device(s).An aortic extender endoprosthesis was implanted to reline the non-gore stent graft and the gore devices.A slight type iii endoleak remained, but the physician decided to monitor it, anticipating thrombosis.It was reported that the 18 fr, 20 fr, and 16 fr sheaths had been cut to approximately 17 cm by the physician before use.The physician stated that the 20 fr sheath was too large for the access vessel.
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.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: asami aizawa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24907684
• Report Number: 3007284313-2026-04713
• Device Sequence Number: 15720087
• Product Code: DYB
• UDI-Device Identifier: 00733132630004
• UDI-Public: (01)00733132630004(17)270831
• 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): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DSF1433
• 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: 03/23/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown