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

Catalog Number	BCL2645
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore tri-lobe balloon catheter warns: excessive inflation volume may result in balloon rupture, embolization, vessel damage, vessel.Additionally, the ifu states, adverse events which may require intervention include, but are not limited to: 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
On (b)(6) 2023, this patient underwent endovascular treatment for a zone 9 infrarenal abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses and a gore® tag® conformable thoracic stent graft with active control system (ctag-ac).The ctag-ac was the most proximal device and was deployed just distal to the lowest renal artery with the excluder trunk having been deployed within the ctag-ac due to the size of the patient aorta and the size of the aneurysm (7cm).Post deployment of all devices and angioplasty of all the devices a small proximal type i endoleak was noted.A second balloon inflation with a gore® tri-lobe balloon catheter (bcl2645/26440564) ensued with the tri-lobe balloon catheter upon which the proximal aorta was noticed to have ruptured.The patient was converted to open wherein all the devices were explanted and a dacron graft was sewn into the aorta.The patient tolerated the procedure.The rupture is believed to have been due to overinflation of the balloon during angioplasty.The explanted devices were discarded at the site.
Additional Manufacturer Narrative
Udi related data quality updates only.D4: corrected udi: (b)(4).

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18270481
• Report Number: 3007284313-2023-02917
• Device Sequence Number: 3905088
• Product Code: DQY
• UDI-Device Identifier: 00733132605224
• UDI-Public: 00733132605224
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 07/18/2024

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: 02/20/2026
• 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: 11/13/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• 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; Hospitalization; Life Threatening
• Patient Age: 85 YR
• Patient Sex: Male