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

Model Number	TGU343415
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); Clinical Endoleak (4843)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following patient information was provided for consideration: medical history: orthostatic hypertension.Surgical history: taaa ascending and descending , appendix medications: taking multivital , taking atorvastatin calcium 40 mg tablet as directed orally once a day, taking carvedilol 12.5 mg tablet 1 tablet with food orally twice a day, taking lisinopril 10 mg tablet as directed orally twice a day.(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.
Event or Problem Description
On (b)(6) 2018, the patient was implanted with conformable gore® tag® thoracic endoprostheses.As reported, on (b)(6) 2022, the patient presented with a possible type ii or type iii endoleak.As reported, there is some concern over access sites on the patient so an angiogram is being planned in order to determine the type of leak and best access and device for use in treatment.As reported, a reintervention will be scheduled based on the results.
Event or Problem Description
On (b)(6) 2018 the patient was implanted with two conformable gore® tag® thoracic endoprosthesis devices to treat a descending thoracic aortic aneurysm.As reported, on (b)(6) 2022, the patient presented with a possible type ii or type iii endoleak.As reported, there is some concern over access sites on the patient so an angiogram is being planned in order to determine the type of leak and best access and device for use in treatment.As reported, a reintervention will be scheduled based on the results.Medical records dated november 18, 2022 stated that the patient followed up with a surveillance imaging which showed an increasing size of the aneurysm with an endoleak.
Additional Manufacturer Narrative
B4: added additional information under describe event or problem.According to the conformable gore® tag®thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to endoleak.The imaging evaluation performed by a clinical imaging specialist showed the following: there are 2 stent grafts implanted, the proximal graft measures ~ 19.9 cm in length along the outer curve.The distal graft measures ~ 19.1 cm in length along the outer curve.Overlap between the two implanted devices measures ~ 14.2 cm.Pages 6-9 show contrast outside of the implanted device on both the arterial and delay phases.There are patent intercostals present.Findings consistent with the reported type ii endoleak.

• 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: 15911482
• Report Number: 2017233-2022-03530
• Device Sequence Number: 17239327
• Product Code: MIH
• UDI-Device Identifier: 00733132618156
• UDI-Public: 00733132618156
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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: 02/13/2020
• Device Model Number: TGU343415
• Device Catalogue Number: TGU343415
• 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: 11/19/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10/H11
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 51 KG