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

Catalog Number	DSF2033
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) , 2025, the patient underwent endovascular treatment for a thoracic aortic aneurysm using a gore® tag® conformable thoracic stent graft with active control system.A 20fr gore® dryseal flex introducer sheath was inserted from the left femoral artery, then the gore® tag® conformable thoracic stent graft with active control system was implanted.After the device implantation, a dissection in the left external iliac artery was observed.A stent was implanted to cover the dissection.The patient tolerated the procedure.The physician stated that the iliac artery was severely tortuous.
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.
Additional Manufacturer Narrative
B5: information added.Emdr section h6, codes d1101 updated to reflect results of investigation.(d1101 was removed) this complaint was initiated based on information received from the field.The reported information indicates a potential device malfunction has occurred where the patient's left external iliac artery dissected after removal of the dsf2033 dryseal sheath.The reported information indicates the patient's access vessel had a diameter as small as 6.3mm, which is too small for the nominal diameter of the dryseal sheath (7.5mm).The device instructions for use provide warning and instruction to ensure the vessel diameter is adequate to accommodate the device.The cause of the reported dissection may be attributed to the use of a device that was too large for the patient's anatomy as reported.
Event or Problem Description
It was reported that the patient's access vessel had a diameter as small as 6.3mm.
Additional Manufacturer Narrative
Emdr section h6, codes d1101 and d12 updated to reflect results of investigation.

• 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: 23785969
• Report Number: 3007284313-2025-04448
• Device Sequence Number: 20220336
• Product Code: DYB
• UDI-Device Identifier: 00733132630066
• UDI-Public: (01)00733132630066(17)280630
• 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,Followup,Followup
• Report Date (Section B): 01/15/2026

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: DSF2033
• Device Lot Number: 30743462
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 11/17/2025; 11/17/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/08/2026; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• 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: Male