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	Embolism/Embolus (4438); Renal Impairment (4499)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2025, this patient underwent an endovascular treatment for pararenal abdominal aortic aneurysm using gore® excluder® thoracoabdominal branch endoprosthesis (tambe).The used devices other than tambe are listed below: gore® viabahn® vbx balloon expandable endoprosthesis: 6 components in total, gore® excluder® aaa endoprosthesis: one contralateral leg, gore® excluder® iliac branch endoprosthesis (ibe): one iliac branch component, gore® dryseal flex introducer sheath (dsf), gore® tri lumen catheter, - gore® molding & occlusion balloon catheter.During the procedure, insertion of a 22fr dsf via the left femoral artery was attempted but was difficult to advance due to calcification.The sheath was exchanged for a 16fr dsf, but similar resistance was encountered.After guidewire exchange, both 16fr and 22fr dfss were advanced with resistance but successfully inserted.While positioning the aortic component, wire wrap occurred and was resolved by rotating the guidewire 360 degrees.The aortic component was deployed without issue.Cannulation of the left renal artery was challenging, but after guidewire exchange, the branch component was successfully placed.Blood flow to the branches was confirmed to be intact, and no proximal type i endoleak was observed.The contralateral leg component was successfully placed on the left side, though a minor distal type i endoleak remained.No additional intervention was performed, and the it was left for monitoring.On the right side, the procedure was completed without device placement, with a plan to embolize the internal iliac artery and land in the external iliac artery two weeks later.After surgical closure, there was no limb ischemia, and urination was normal.On the same day as the procedure, the patient complained of abdominal distension, and contrast-enhanced ct was performed.Embolization of renal arteries, superior mesenteric artery and lower extremities due to blood clot scattering was found.The patient developed renal dysfunction.Reportedly, the patient had multiple mural thrombi in the thoracic descending aorta.Intraoperative angiography showed good blood flow in all abdominal branches.On an unknown date, the patient started dialysis and received open surgery to partially resect the intestine.At the time of this report, the patient was doing well and the second stage procedure was scheduled for (b)(6) 2025.

• 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: tatsuya sato ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23591329
• Report Number: 3007284313-2025-04378
• Device Sequence Number: 9859774
• Product Code: MJN
• UDI-Device Identifier: 00733132639489
• UDI-Public: (01)00733132639489(17)280405
• 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): 11/19/2025

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: 10/22/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2025
• 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