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

Catalog Number	DSF1833
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Literature title: femoro-femoral bypass for a vascular complication during transfemoral aortic valve implantation.Source: cureus 2025;17(3):e81239.Https://doi.Org/10.7759/cureus.81239.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 publication was reviewed by gore: omote k, kamada t, furugen m, et al.Femoro-femoral bypass for a vascular complication during transfemoral aortic valve implantation.Cureus 2025;17(3):e81239.Https://doi.Org/10.7759/cureus.81239.A (b)(6) year-old woman underwent transcatheter aortic valve implantation (tavi) for treatment of severe aortic stenosis (as) on (b)(6) 2024.Final angiography showed the right external iliac artery occlusion due to vascular injury related to a large-diameter introducer sheath (gore® dryseal flex introducer sheath).Although we performed endovascular therapy, no guidewires could cross the culprit lesion because the intima had frapped and occluded the vessel lumen.Therefore, we performed femoro-femoral bypass (gore® propaten® vascular graft) for bailout of acute limb ischemia.Femoro-femoral bypass is a less invasive, shorter operation time and therefore a reasonable strategy as an urgent bailout for vascular complications during tavi in super-aged or higher-risk surgical patients with severe as.
Additional Manufacturer Narrative
Emdr section h6, codes c19 and d15 updated to reflect results of product history review.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.

• 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: ayako yoshioka ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23723042
• Report Number: 3007284313-2025-04425
• Device Sequence Number: 10349758
• Product Code: DYB
• UDI-Device Identifier: 00733132630042
• UDI-Public: (01)00733132630042(17)250830
• 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,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2025
• Device Catalogue Number: DSF1833
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2022
• 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 Sex: Female