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

Catalog Number	TGU404020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	06/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.Code c21: a review of the manufacturing records for the device is going to be conducted.The investigation is in process.The device remains implanted and is not available for investigation.Additional information was requested from the site and will be provided.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.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
The following information was reported to gore: it was reported that on an unknown date, the patient underwent an endovascular procedure to treat a descending thoracic aortic aneurysm using a non-gore device.On (b)(6), 2015, a reintervention of a prior endovascular procedure was done to treat a zone 4 descending thoracic aortic aneurysm using a conformable gore® tag® thoracic endoprosthesis (tgu404020/ 14185643).The patient tolerated the procedure and discharged home on (b)(6), 2015.Reportedly, pre-treatment cta showed that the maximum diameter of the aortic aneurysm/lesion was 65mm.The follow up cta on (b)(6) 2017, showed that the maximum diameter of the aortic aneurysm/lesion was 61mm.On (b)(6), 2017, the patient underwent an additional zone 2 descending thoracic aortic aneurysm treatment with a proximal type i endoleak from the previous repair using a gore® tag® thoracic endoprosthesis and gore® tag® thoracic branch endoprostheses.Additionally, the patient underwent revascularization procedure.The patient tolerated the procedure and discharged home on (b)(6), 2017.On (b)(6), 2017, the follow up cta showed that the maximum diameter of the aortic aneurysm/lesion was 33mm.No further adverse events have been reported.Code 5400:c- other/unknown was used to cover a revascularization procedure.
Event or Problem Description
This report was sent as a retraction due to the information received that a proximal device implanted in 2005 at the zone 2 was a medtronic device.The proximal type i endoleak was at the zone 2 and the proximal device (medtronic) had a reintervention.A gore® tag® thoracic endoprosthesis was implanted at zone 4.There is no allegation against the gore device.This case is not reportable.
Additional Manufacturer Narrative
This report was sent as a retraction due to the information received that a proximal device implanted in 2005 at the zone 2 was a medtronic device.The proximal type i endoleak was at the zone 2 and the proximal device (medtronic) had a reintervention.A gore® tag® thoracic endoprosthesis was implanted at zone 4.There is no allegation against the gore device.This case is not reportable.

• Brand Name: CONFORMABLE GORE® TAG®THORACIC 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19347765
• Report Number: 2017233-2024-04951
• Device Sequence Number: 6614737
• Product Code: MIH
• UDI-Device Identifier: 00733132617760
• UDI-Public: 00733132617760
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2018
• Device Catalogue Number: TGU404020
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2015
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Race: White