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

Catalog Number TSB080806C

Device Problems Complete Blockage (1094); Obstruction of Flow (2423); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/03/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the patient underwent treatment of a zone 1 thoracic aortic aneurysm with gore® tag® thoracic branch endoprostheses (tbe).On february 22, 2022, core lab pre-treatment imaging showed that the maximum thoracic aortic aneurysm diameter was 49.5mm.Core lab imaging from june 3, 2022 to june 12, 2023 showed that the maximum aortic diameter decreased in size from 34mm to 20mm.Also, it was noted loss of patency at the tbe side branch device.Reportedly, lcca side branch component is occluded and there is no contrast enhancement visualized at the lsa/lcca bypass.The event is ongoing.According to the physician, a device occlusion was due to covid infection.Reportedly, the device was used according to the ifu and was ballooned by the tbc 48c during the procedure.The physician does not plan to treat the occlusion.The patient is doing fine and is going to have a follow up visit between (b)(6) 2024 and (b)(6) 2024.

Manufacturer Narrative

Code c21- a review of the manufacturing record for the device is going to be conducted.The investigation is in process.The device remains implanted and is not available for investigation.Code e2402 was used to cover covid infection which caused a device occlusion.Code f28 was used to explain that the physician is monitoring the patient.Further information was requested.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.

Manufacturer Narrative

Code e2402 was used to cover covid infection which caused a device occlusion.Code f28 was used to explain that the physician is monitoring the patient.H6: code c19: a review of the manufacturing records for the device verified the lot met all pre-release specifications.The device remains implanted and is not available for analysis.According to the physician, a device total occlusion was due to covid infection.According to the gore® tag® thoracic branch endoprosthesis instructions for use (ifu), possible adverse events and complications that may occur with the use of gore® tag® thoracic branch endoprosthesis include, but are not limited to endoprosthesis occlusion.

Event Description

According to the physician, a device total occlusion was due to covid infection.The physician does not plan to treat the occlusion.The patient is doing fine.

• Brand Name: GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS
• Type of Device: 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18647758
• MDR Text Key: 334611886
• Report Number: 2017233-2024-04598
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P210032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2024
• Device Catalogue Number: TSB080806C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White