MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TRI-LOBE BALLOON CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	BCL2645
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code c19-a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.H6: code b20-the device remains implanted and, therefore, was not available for direct analysis by gore.H6: code d15-there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.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
On (b)(6) 2026, the patient underwent a thoracic endovascular procedure to treat a penetrating atherosclerotic (pau) utilizing gore® tag® thoracic branch endoprosthesis (tbe) and gore® tri-lobe balloon catheter.It was reported a tbe aortic extender was implanted at the proximal edge of the tbe aortic component.Upon physician ballooning the overlap between the tbe aortic component and tbe aortic extender, a little bit of waste was noted on the lesser curve of the aorta and appeared to pop out.Allegedly, the balloon was noted to be fully inside the graft, however the ballooning appeared to rupture the ascending aorta.It was also reported the patient coded after the ballooning was performed, and was converted to open heart repair.The patient is alive and is on bypass.Physician does not know what caused this issue, as no excessive force was used for ballooning.No further patient information is available.

• Brand Name: GORE® TRI-LOBE BALLOON CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24639195
• Report Number: 3007284313-2026-04636
• Device Sequence Number: 9797555
• Product Code: DQY
• UDI-Device Identifier: 00733132605224
• UDI-Public: (01)00733132605224(17)281123
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: BCL2645
• 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: 02/20/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2025
• 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 Age: 76 YR
• Patient Sex: Unknown