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

Model Number	TGU454520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	01/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016, a patient underwent treatment of a thoracic aneurysm, zone 2, with gore® tag® thoracic branch endoprosthesis (tbe device) and extension below this with two gore® tag® conformable thoracic stent grafts with active control system.On (b)(6) 2017, the maximum aortic diameter within the treated area was 43mm.On (b)(6) 2017, the maximum aortic diameter within the treated area was 31mm.On (b)(6) 2018, the maximum aortic diameter within the treated area was 54mm.On (b)(6) 2022, the maximum aortic diameter within the treated area was 53mm and a right femoral aneurysm was identified.
Additional Manufacturer Narrative
Concomitant medications: aspirin (81mg).Medical history: myocardial infarction, percutaneous coronary intervention, previous aortic surgery, asa physical status classification: iii, severe systemic disease with definite functional limitation d10: as gore was unable to determine which device(s) caused or contributed to the event if any; additional device(s) implanted related to this event include the following as referenced in 10514-2 brand: conformable gore® tag® thoracic endoprosthesis product name: stent graft thoracic conformable, catalog number: tgu454520, lot/sn: (b)(4), udi: (b)(4).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
Added g code, as it was previously omitted.

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15528843
• Report Number: 2017233-2022-03373
• Device Sequence Number: 14125787
• Product Code: MIH
• UDI-Device Identifier: 00733132617753
• UDI-Public: 00733132617753
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 12/06/2022

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: 08/13/2018
• Device Model Number: TGU454520
• Device Catalogue Number: TGU454520
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2015
• 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: Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 100 KG