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	Vascular Dissection (3160)
Date of Event	03/11/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
-patient medications: aspirin, moxifloxacin, doxycycline, cipro, vancomycin, percocet and penicillin.The gore® tri-lobe balloon catheter instructions for use (ifu) states that adverse events include, but are not limited to trauma to the vessel wall, including perforation, and death 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 field sales associate reported the following: on (b)(6) 2025, the patient was implanted with gore® tag® conformable thoracic stent graft with active control system with a gore® tri-lobe balloon catheter to treat a thoracic dissection with an intramural hematoma present.It was reported that after deploying the gore® tag® conformable thoracic stent graft with active control system (tgmr313110/(b)(6), images revealed a proximal type i endoleak.The physician chose to use a gore® tri-lobe balloon catheter to balloon the endoleak.Reportedly the physician was ¿aggressively¿ ballooning the proximal endoleak and perforated the aorta.While retracting the balloon the patient coded.The physician implanted an additional gore® tag® conformable thoracic stent graft with active control system (tgmr313110/(b)(6) to treat the perforated aorta.A blood transfusion was required.The patient never recovered from the code and expired in the operating room.Reportedly the patient had a friable aorta with history of cardiac issues and peripheral vascular disease.During the code the patient developed a pleural effusion from the bleeding.

• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21703660
• Report Number: 3007284313-2025-03857
• Device Sequence Number: 4745484
• Product Code: DQY
• UDI-Device Identifier: 00733132605224
• UDI-Public: (01)00733132605224(17)260627
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K180919
• 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): 03/26/2025

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 Expiration Date: 06/27/2026
• 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: 03/11/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Death
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 77 KG