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

Model Number	BCM1634
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	12/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the patient underwent endovascular treatment of a zone 0 thoracic aortic aneurysm using gore® tag® thoracic branch endoprostheses.It was noted that the patient's anatomy was extremely tortuous.It was reported that the patient experienced a stroke post procedure.The physician also noted that it may have occurred intra procedure.Reportedly the cause of the stroke is unknown, but it was suspected to be related to wire and device manipulation.Due to the anatomical tortuosity, there was also difficulty reported while attempting to align the portal of the thoracic branch aortic component to the outer curve in aortic zone 0.It was reported that the patient remained in the hospital post procedure for stroke complications including aphasia.On (b)(6) 2023, the physician reported that the patient's aphasia was significantly improved, and the patient was walking with the physical therapist.The patient was reportedly discharged to home on or about (b)(6) 2022.
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #: tgm343420, serial #: 25056840, udi #: (b)(4) and catalog #: tgm343410, serial #: (b)(4), udi #: (b)(4) which have been captured in manufacturer report #2017233-2023-03658.Catalog #: tac123415a, serial #: (b)(4), udi #: (b)(4) and catalog #: tsb121506a, serial #: (b)(4), udi #: (b)(4) which have been captured in manufacturer report #: 2017233-2023-03657.Patient weight: asked but unavailable.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.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.
Additional Manufacturer Narrative
H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation conclusions: code d12 added.According to the gore® tri-lobe balloon catheter instructions for use, potential device or procedure related adverse events which may or may not require intervention include, but are not limited to, stroke.H.6.Investigation findings for analysis of production records: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d15.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16221811
• Report Number: 3007284313-2023-02309
• Device Sequence Number: 14821102
• Product Code: DQY
• UDI-Device Identifier: 00733132605231
• UDI-Public: 00733132605231
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/15/2023

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: 05/23/2024
• Device Model Number: BCM1634
• Device Catalogue Number: BCM1634
• 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: 12/23/2022
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 01/22/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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
• Patient Age: 78 YR
• Patient Sex: Female