MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TGU373715
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); No Code Available (3191)
Date of Event	08/20/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoleak and aneurysm enlargement.Additionally, users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Please note, that the date of event will be used (b)(6) 2015, the date when the endoleak was discovered.
Event or Problem Description
On (b)(6) 2015, a patient underwent treatment for a 75.5mm saccular aneurysm of the proximal descending thoracic aorta using a conformable gore® tag® thoracic endoprosthesis.Reportedly, from (b)(6) 2015 till (b)(6) 2019, the follow up computed tomography (ct) observed an indeterminate endoleak.Additionally, a ct showed that the maximum diameter of aortic aneurysm/lesion increased in size from 75mm to 80mm.On (b)(6) 2019, the endoleak was suspected to be a type ii endoleak.The cause/origin of endoleak will be determined at the next visit.No treatment was required.The physician is monitoring the patient.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9360028
• Report Number: 2017233-2019-01170
• Device Sequence Number: 13976517
• Product Code: MIH
• UDI-Device Identifier: 00733132618187
• UDI-Public: 00733132618187
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

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: 05/26/2018
• Device Catalogue Number: TGU373715
• Device Lot Number: 13978688
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Weight: 95