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

Catalog Number	DSF1245
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: the device history record was reviewed to ensure that each manufacturing and inspection operation was performed and indicated the product met the specifications and procedures.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 information was reported to gore: on (b)(6) 2026, this patient underwent an endovascular treatment for pararenal abdominal aortic aneurysm using gore® excluder® thoracoabdominal branch endoprosthesis (tambe).Gore® excluder® aaa endoprosthesis, gore® excluder® iliac branch endoprosthesis (ibe) and gore® viabahn® vbx balloon expandable endoprosthesis were concomitantly implanted as system components.All planned devices were successfully deployed.The patient tolerated the procedure.Postoperatively, a splenic infarction was identified on a follow-up ct scan conducted between (b)(6) 2026 (exact date unknown).Although the relationship to the splenic infarction is unclear, the patient complained of lower back pain.There were no other symptoms, and no treatment was provided for the splenic infarction.The physician suspected that blood clots present in the aortic arch may have been dislodged during the procedure, leading to the splenic infarction.Gore devices inserted via the axillary artery and passing through the aortic arch included the gore® dryseal flex introducer sheath (12fr, 45 cm).It was also reported that guidewires and catheters traversing the aortic arch could have contributed as potential causes.

• 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: tatsuya sato ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25701367
• Report Number: 3007284313-2026-04900
• Device Sequence Number: 18578765
• Product Code: DYB
• UDI-Device Identifier: 00733132628117
• UDI-Public: (01)00733132628117(17)270730
• 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): 07/03/2026

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: DSF1245
• 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: 06/10/2026
• Initial Report FDA Received Date: 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male