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

Catalog Number TAC124515C

Device Problem Insufficient Information (3190)

Event Date 02/12/2024

Event Type  Injury  

Manufacturer Narrative

H6.Code c21: a review of manufacturing records is going to be conducted.The investigation is in process.The device remains implanted and is not available for analysis.Code f28 was used to explain that the event is ongoing and the physician is monitoring the patient.The patient is pending the additional surgery.The date is unknown.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 Description

On (b)(6) 2023, the patient underwent an endovascular treatment of a zone 0 thoracic aortic aneurysm with a conformable gore® tag® thoracic endoprosthesis and a gore® tag® thoracic branch endoprosthesis.The patient tolerated the initial procedure.The images provided by site showed that the pre-treatment maximum aneurysm/ lesion was 81.6mm.The follow up scans provided by site showed that the aneurysm decreased in size to 78.1mm.On (b)(6) 2023, the site follow up imaging showed that the maximum aneurysm/ lesion was 76mm.On (b)(6) 2024, the core lab follow up imaging noted an indeterminate endoleak associated with an aortic component.The maximum aneurysm/ lesion measured by the core lab and confirmed by the site was 80mm.The patient is pending the additional surgery.The date is not available yet.The endoleak is ongoing.The physician is monitoring the patient.

Event Description

On (b)(6) 2023, the patient underwent an endovascular treatment of a zone 0 thoracic aortic aneurysm with a conformable gore® tag® thoracic endoprosthesis and a gore® tag® thoracic branch endoprosthesis.The patient tolerated the initial procedure.The images provided by the site showed that the pre-treatment maximum aneurysm/ lesion was 81.6mm.The follow up scans provided by site showed that the aneurysm decreased in size to 78.1mm.On (b)(6) 2023, the site follow up imaging showed that the maximum aneurysm/ lesion was 76mm.On (b)(6) 2024, the core lab follow up imaging noted an indeterminate endoleak associated with an aortic component.The maximum aneurysm/ lesion measured by the core lab and confirmed by the site was 80mm.The patient was pending the additional surgery.The date was not available.The endoleak was ongoing.The physician was monitoring the patient.On (b)(6) 2024, the patient underwent an endovascular procedure to treat a proximal type i endoleak using a gore® ascending stent graft (asg device).It is unknown if it is a new endoleak or a proximal type i endoleak determined on (b)(6) 2023.The patient tolerated the procedure.The physician is monitoring the patient.

Manufacturer Narrative

H.6.Code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted and is not available for analysis.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 aortic expansion, endoleak and reoperation.Device related risks include endoleak, lesion enlargement or progression, potential for reintervention and open surgical conversion.Additional surveillance and possible treatment is recommended for a type i endoleak and lesions enlargement = 5 mm increase in maximum diameter (regardless of endoleak status) compared to any previous measurement.

• 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: 19076926
• MDR Text Key: 339775312
• Report Number: 2017233-2024-04811
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• 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: 05/13/2024

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: 03/01/2024
• Device Catalogue Number: TAC124515C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• 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): Required Intervention; Other; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander