MAUDE Adverse Event Report: W. L. Gore & Associates, Inc. GORE® Molding & Occlusion Balloon Catheter; Catheter, Intravascular Occluding, Temporary

Catalog Number	MOB37
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Embolism/Embolus (4438)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2026, the patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm.A gore® excluder® thoracoabdominal branch endoprosthesis, a gore® tag® conformable thoracic stent graft with active control system and four gore® viabahn® vbx balloon expandable endoprosthesis devices were implanted using two gore® dryseal flex introducer sheath (22fr and 14fr), a gore® tri lumen catheter and a gore® molding & occlusion balloon catheter.The 22fr gore® dryseal flex introducer sheath was inserted from the left femoral artery and the 14fr gore® dryseal flex introducer sheath was inserted from the left axillary artery.After implantation of all devices, angiography revealed a rupture and dissection extending from the left external iliac artery to the left common femoral artery.A gore® viabahn® vbx balloon expandable endoprosthesis and a gore® viabahn® endoprosthesis with heparin bioactive surface were implanted in the left external iliac artery to treat the rupture.Subsequently, the 22 fr gore® dryseal flex introducer sheath inadvertently backed out.Two additional gore® viabahn® vbx balloon expandable endoprosthesis devices were implanted using a crossover approach from the right femoral access through an 8 fr sheath.Then, angiography confirmed that hemostasis had been achieved and that flow in the left internal iliac artery had disappeared.It was reported that blood flow in the left internal iliac artery was still present at the time of the angiography that identified the left access injury.It was considered that loss of blood flow in the left internal iliac artery occurred at some point during implantation of the vbx and vsx devices in the left external iliac artery.An endarterectomy was performed for the distal dissection.Because distal blood flow remained poor, graft replacement of the femoral artery was subsequently performed.It was reported that the diameter of the left external iliac artery to the left common femoral artery was approximately 6mm.
Additional Manufacturer Narrative
A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Please note that the same patient was captured in medwatch report number 3007284313-2026-05108.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.

• Brand Name: GORE® Molding & Occlusion Balloon Catheter
• Common Device Name: Catheter, Intravascular Occluding, Temporary
• 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 ; +1(928)526-3030
• MDR Report Key: 50911714
• Report Number: 3007284313-2026-05109
• Device Sequence Number: 14897459
• Product Code: MJN
• UDI-Device Identifier: 00733132639489
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172567
• 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): 09/28/2026

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: MOB37
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male