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

Catalog Number	DSF1245
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/07/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported to gore, that on (b)(6) 2026, a patient with pararenal aneurysm was implanted with a gore® tag® conformable thoracic stent graft with active control system, gore® excluder® thoracoabdominal branch endoprosthesis (tambe) system, and a gore® excluder® aaa endoprosthesis.A vascular access via the right axillary artery was made for the introduction of the tambe branch components, where a 12 fr gore® dryseal flex introducer sheath (dsf) was used.On the same date, the patient suffered a type a dissection with the primary entry tear in the ascending aorta, extending into the descending aorta.It is not known if this dissection reached the most proximal implanted device.A supracoronary ascending aorta replacement (scar) was performed.Initially, the patient appeared to have recovered well but unfortunately passed away on (b)(6) 2026.The physician reported that the dsf, which was introduced pass the brachiocephalic trunk, into the aortic arch and down the descending thoracic aorta, is the cause of the type a dissection.
Additional Manufacturer Narrative
D10: concomitant medical products: (relevant associated devices used with the device being reported on): gore® excluder® thoracoabdominal branch endoprosthesis (tambe) system.H6: code e0515: e051501 should be used instead of e0515 (due to system limitations).Code b14: product history review is ongoing.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.
Additional Manufacturer Narrative
H6: updated investigation findings code to c19, code c21 is no longer applicable.Updated investigation conclusions code to d15, code d16 is no longer applicable.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.This complaint was initiated based on information received from the field.The information reported in the complaint does not reasonably suggest a potential malfunction or product packaging and/or labeling issue has occurred.Neither images enabling direct assessment of product performance nor the product itself were returned for evaluation.The reported aortic dissection represents a known complication or adverse event that can occur when using the device.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25274360
• Report Number: 3007284313-2026-04802
• Device Sequence Number: 9685962
• Product Code: DYB
• UDI-Device Identifier: 00733132628117
• UDI-Public: (01)00733132628117(17)280117
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 06/29/2026

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: 05/13/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Race: White