MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TAC083415A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #tsb081006a / serial # (b)(4) / udi # (b)(4).Patient weight: this information has been requested, but has not yet been provided to gore.Other relevant history, including preexisting medical conditions: this information has been requested, but has not yet been provided to gore.As the gore® tag® thoracic branch endoprosthesis - side branch component is being included in this report as the same system of components, applies to this device.Name: cbas® heparin surface manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 25644778 cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Concomitant medical products and therapy dates: this information has been requested, but has not yet been provided to gore.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) 2022, the patient underwent endovascular treatment using gore® tag® thoracic branch endoprostheses (tbe).It was reported that the patient had a mild stroke postop with left sided weakness.Reportedly, the tbe device never crossed the innominate artery during the procedure.It was further noted that the patient was appropriately heparinized during the procedure.
Additional Manufacturer Narrative
H.6.Type of investigation: code b14 remains unchanged.H.6.Type of investigation: code b15 remains unchanged: images were provided, and an imaging evaluation was performed.H.6.Investigation findings: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation findings: code c19 - the imaging evaluation was performed by a clinical imaging specialist.The evaluation showed the following: one time-point available for evaluation: pre-implantation cta dated 10/20/2022.Imaging available demonstrates the presence of calcium and thrombus within the thoracic aortic arch distal to the lsa.Imaging also identifies calcium in the distal ascending thoracic aorta.Axial imaging shows a flow lumen irregularity within the arch.Calcium is also identified in the abdominal aorta and common iliac arteries (especially in the right common iliac artery).H.6.Investigation conclusions: code d16 remains unchanged h.6.Investigation findings: code c21 updated to code c19.H.6.Investigation findings: code c21 updated to code c19.
Event or Problem Description
The patient underwent endovascular treatment of a zone 2 thoracic aortic aneurysm.The cause of the postop stroke was reportedly unknown.No stroke treatment was performed.As of (b)(6) 2023, the patient was reported to have fully recovered with no lasting neurological deficit.
Additional Manufacturer Narrative
A.4.Patient weight: asked but unavailable.B.7.Other relevant history, including preexisting medical conditions: asked but unavailable.D.10.Concomitant medical products and therapy dates: asked but unavailable.H.6.Investigation conclusions: code d12 added.According to the gore® tag® thoracic branch endoprosthesis instructions for use, potential adverse events or complications that may occur with the use of the gore® tag® thoracic branch endoprosthesis include, but are not limited to, transient ischemic attack and neurologic damage, local or systemic (e.G., stroke, paraplegia, paraparesis).G.3.Date received by manufacturer: initial date updated/corrected from 06-dec-2022 to 07-dec-2022.H.6.Investigation findings for communication/interviews: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d15.

• Brand Name: GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16092097
• Report Number: 2017233-2023-03614
• Device Sequence Number: 6559478
• Product Code: MIH
• UDI-Device Identifier: 00733132654093
• UDI-Public: 00733132654093
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2023

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: 01/23/2025
• Device Model Number: TAC083415A
• Device Catalogue Number: TAC083415A
• 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: 12/06/2022
• Supplement Date Received by Manufacturer: 01/05/2023; 02/21/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/02/2023; 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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: 83 YR
• Patient Sex: Female