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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/16/2025
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.H6: code d12: ifu statements: the molding & occlusion balloon and contralateral leg device instructions for use (ifu) were reviewed with respect to the complaint detail for the applicable region and time period, and the following ifu statements were identified in relation to the complaint.Contralateral leg: warnings on usage 10.Do not change the location of the endoprosthesis once it has started to be deployed.[otherwise, it may end up causing vascular damage or being placed in the wrong location.] possible defects and adverse events include: 1) severe adverse events: vascular spasm or vascular trauma (eg., ilio-femoral artery dissection, excessive bleeding, vascular rupture, mortality).Molding & occlusion balloon: 4) do not advance or retract the balloon catheter while the balloon is inflated.[if the balloon is advanced while the balloon is inflated, it may result in prosthesis movement, vessel damage and/or catheter damage.] 2.Device defects and adverse events: anticipated device defects and adverse events are as follows: trauma to the vessel wall, including spasm, dissection, perforation or rupture.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 abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis and gore® excluder® aaa endoprosthesis.When deploying a contralateral leg component on the left side, the internal iliac artery was unintentionally covered.The physician attempted to push the contralateral leg up by a gore® molding & occlusion balloon catheter.After this attempt, rupture of the left common iliac artery was confirmed.An iliac extender was placed to cover the ruptured site.The procedure was concluded with unintentional coverage of the left internal iliac artery.The reporting physician commented as follows: during angiography, the left iliac bifurcation was misread.

• 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: 21983008
• Report Number: 3007284313-2025-03961
• Device Sequence Number: 14574725
• Product Code: MJN
• UDI-Device Identifier: 00733132639489
• UDI-Public: (01)00733132639489(17)271021
• 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): 05/08/2025

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: 04/16/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2024
• 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: 79 YR
• Patient Sex: Female