MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (VER 1.5); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TGT3715
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); No Code Available (3191)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Further information was requested but was not available.According to the gore® tag® thoracic endoprosthesis instructions for use, complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to endoleak and reoperation.
Event or Problem Description
On (b)(6) 2013, the patient underwent endovascular repair of a thoracic aortic dissection using a gore® tag® thoracic endoprosthesis.The patient tolerated the procedure.On an unknown date, a follow up imaging showed a suspected proximal type i endoleak.On (b)(6) 2019, an additional procedure was performed to treat the suspected type i endoleak.The preoperative imaging did not identified the proximal type i endoleak.A conformable gore® tag® thoracic endoprosthesis was implanted proximally.The patient tolerated the procedure.
Additional Manufacturer Narrative
Corrected information: b3: as the date of the suspected type i endoleak and the aneurysm enlargement is unknown, the reintervention date (b)(6) 2019 will be used as an event date.
Event or Problem Description
On an unknown date, a follow up imaging showed a suspected proximal type i endoleak.Additionally, the aneurysm enlargement was observed (amount unknown).
Additional Manufacturer Narrative
According to the gore® tag® thoracic endoprosthesis instructions for use, complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to endoleak , aortic expansion (e.G., aneurysm) and reoperation.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (VER 1.5)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8602161
• Report Number: 2017233-2019-00342
• Device Sequence Number: 2339769
• Product Code: MIH
• UDI-Device Identifier: 00733132613670
• UDI-Public: 00733132613670
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2019

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: 07/31/2013
• Device Catalogue Number: TGT3715
• Device Lot Number: 8297026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 05/21/2019; 06/06/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR