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

Model Number	TSB081206A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the patient underwent endovascular treatment of a thoracic aortic aneurysm using gore® tag® thoracic branch endoprostheses.On (b)(6) 2023, the gore representative was informed that the patient had a stroke on an unknown date.Additional information was requested.
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #: tac084515a/ serial #: (b)(6)/ udi #: (b)(4) as the same device family.A.4.Patient weight: this information was requested, but remains unavailable to gore at this time.B.7.Other relevant history, including preexisting medical conditions: this information was requested, but remains unavailable to gore at this time.C.1.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.D.10.Concomitant medical products and therapy dates: this information was requested, but remains unavailable to gore at this time.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
B.4.Event description: additional information added/updated h.6.Investigation conclusions: code d15 and code d12 remain unchanged.
Event or Problem Description
The patient underwent endovascular treatment of a type b thoracic aortic dissection in zone 2.It was noted that the physician experienced difficulty orienting the portal of the aortic component (ac) to the ostium of the patient's left subclavian artery.Upwards of six passes across the aortic arch were made with the ac device in an attempt to achieve the desired orientation.Eventually, the physician accepted the ac orientation and the procedure was completed with implantation of both the ac and a side branch device.
Additional Manufacturer Narrative
A.4.Patient weight: added.B.4.Event description: additional information added.B.7.Other relevant history, including preexisting medical conditions: added.D.10.Concomitant medical products and therapy dates: rosuvastatin, clopidogrel, eliquis, amlodipine, bupropion, levothyroxine.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® tag® thoracic branch endoprosthesis instructions for use, potential adverse events and/or complications that may occur with the use of the gore® tag® thoracic branch endoprosthesis include, but are not limited to, embolism (micro and macro) with transient or permanent ischemia, and neurologic damage, local or systemic (e.G., stroke, paraplegia, paraparesis).B.3.Date of event: updated.H.6.Health effect - impact code: code f24 updated to code f18.H.6.Medical device problem code: code a26 updated to code a0101.H.6.Investigation findings for analysis of production records: code c21 updated to code c19.H.6.Investigation findings for communication/interviews: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d15.
Event or Problem Description
On (b)(6) 2023, the gore representative was informed that the patient had experienced an embolic stroke post operatively on (b)(6) 2023.An mra of the patient's brain and a cta of the patient's head were performed.No stroke treatment was performed, but the patient had speech, occupational, and physical therapy.It was reported that the patient was discharged to a rehabilitation facility.

• 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: 17222658
• Report Number: 2017233-2023-04071
• Device Sequence Number: 6970018
• Product Code: MIH
• UDI-Device Identifier: 00733132654376
• UDI-Public: 00733132654376
• 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: 2023
• 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): 08/28/2023

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: 08/17/2025
• Device Model Number: TSB081206A
• Device Catalogue Number: TSB081206A
• 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: 06/01/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 08/28/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/09/2023; 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 FOR LIST OF MEDICATIONS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 83 KG