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

Catalog Number	DSF2033
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As gore was unable to determine which device/device component is involved in this reportable adverse event, the following additional devices will be identified in this report: catalog#: dsf2233, serial#: (b)(6), udi: (b)(4), catalog#: dsf1433, serial#: (b)(6), udi: (b)(4), and catalog#: dsf1245, serial#: (b)(6), udi: (b)(4).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 have not 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 thoracoabdominal aortic aneurysm using gore® excluder® thoracoabdominal branch endoprosthesis (tambe).The patient previously had already been implanted with gore® excluder® aaa endoprosthesis in the abdominal aorta on an unknown date.In this tambe procedure, gore® dryseal flex introducer sheath, gore® tri-lobe balloon catheter, gore® molding & occlusion balloon catheter, and gore® tri lumen catheter (tlc) were used as accessory devices.Gore® viabahn® endoprosthesis with heparin bioactive surface (vsx) and gore® viabahn® vbx balloon expandable endoprosthesis (vbx) were used as branch components.During establishment of pull-through guidewire, a 0.018-inch guidewire could not be removed from the tlc catheter with significant resistance felt.As the guidewire was unable to be removed safely, the tlc catheter was withdrawn and exchanged for a new one.After deploying the tambe device, cannulation to the left renal artery from the upper extremity approach was challenging due to superiorly angulated renal artery.Although a guidewire could be advanced into the left renal artery, the severe angle prevented advancement of the angiographic catheter and stiff wire, making planned vbx placement unsuccessful from the arm approach.A femoral approach was then used to access the left renal artery.A vsx device followed by multiple vbx devices were deployed distally in a snorkel configuration to maintain renal blood flow.In addition, a vbx stent graft was deployed within the left renal artery portal of the tambe, and the portal was embolized with a plug and coils.As bridging devices between the tambe and previous excluder, a vela infrarenal endograft (afx2 system) and an aortic extender of excluder were used.The patient tolerated the procedure.On the same day as the procedure, the patient developed thromboembolism of the left popliteal artery.Thrombectomy was performed on the same day, resulting in restoration of blood flow.The patient was under hospitalization and no further health injury remained.The reporting physician commented as follows: (1) the left renal artery was highly angulated and insertion of vbx device was difficult.(2) since there were a large amount of mural thrombi in the aneurysmal sac, intraoperative catheter and device manipulation within the aneurysm was the most likely cause of thromboembolism.
Additional Manufacturer Narrative
H6: investigation findings and conclusions were updated to reflect the results of investigation.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: tatsuya sato ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24950191
• Report Number: 3007284313-2026-04725
• Device Sequence Number: 18668435
• Product Code: DYB
• UDI-Device Identifier: 00733132630066
• UDI-Public: (01)00733132630066(17)281012
• 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
• Report Date (Section B): 05/11/2026

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
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male