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

Model Number	TGU373715
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code c20- a review of the manufacturing records for the device is going to be conducted.The investigation is in process.Further information is going to be provided.Also was implanted tgu373710/unknown.The device information was requested, however it is not available.The devices remain implanted and are not available for investigation.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 a (b)(6) 2018, a patient underwent treatment of a zone 2 thoracic aortic dissection with two gore® tag® thoracic branch endoprostheses and one conformable gore® tag® thoracic endoprostheses as distal extension to aortic component.According to the report all devices were positioned and implanted without issue.Core lab pre-treatment imaging on (b)(6) 2018, showed that the maximum aneurysm/ lesion was 52.5mm.On (b)(6)2018 a false lumen perfusion distal to the device was noted.The maximum aortic diameter was 62mm.On (b)(6) 2018 a reintervention occurred whereby a second ctag device (tgu373710/unknown) was implanted and an embolization procedure of the intercostal vessels with a plug was performed.The patient tolerated the procedure.From (b)(6) 2018 to (b)(6) 2020, core lab follow up imaging revealed that the maximum aortic diameter within treated segment was increased in size from 62mm to 69mm.From (b)(6) 2018 to (b)(6) 2020, core lab follow up imaging revealed that the maximum false lumen diameter decreased from 59.1mm to 23.4mm.On (b)(6) 2020, a distal persistent false lumen perfusion was reported.On (b)(6) 2020, the patient underwent an embolization procedure.Please note that the site confirmed the aneurysm enlargement, the false lumen perfusion and the treatment as an adverse event.
Additional Manufacturer Narrative
H6: code c19- a review of the manufacturing records for the device verified the lot met all pre-release specifications.Also was implanted tgu373710/unknown.The device information was requested, however it is not available.The devices remain implanted and are not available for investigation.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to dissection, aortic expansion (e.G., aneurysm) and reoperation.

• 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: 16969633
• Report Number: 2017233-2023-03945
• Device Sequence Number: 5225189
• Product Code: MIH
• UDI-Device Identifier: 00733132618187
• UDI-Public: 00733132618187
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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: 04/29/2021
• Device Model Number: TGU373715
• Device Catalogue Number: TGU373715
• 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: 04/28/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• 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; Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American