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

Catalog Number	TGT3720
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the 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 aortic expansion (e.G., aneurysm, false lumen, landing zone, lesion) and reoperation.As date of the disease progression is unknown, the reintervention date (b)(6) 2019 will be used as an event date.
Event or Problem Description
On (b)(6) 2013, this patient underwent endovascular treatment using two gore® tag® thoracic endoprostheses by frozen elephant trunk technique for descending aortic aneurysm.During the procedure, it was noted a slight type iii endoleak.The physician chose to monitor the endoleak.The patient tolerated the procedure.On an unknown date, a follow-up examination revealed the disease progression into the distal side.The distal side of the device became aneurysmal.According to the information provided, it was a natural disease progression that was beyond the device's control.On (b)(6) 2019, the patient underwent reintervention to treat the disease progression.A gore® tag® conformable thoracic stent graft with active control system was deployed to extend the device distally.As an accompanying of the procedure of device deployment, a coil embolization in the aneurysm sac was performed.The patient tolerated the procedure.

• 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: 9566922
• Report Number: 2017233-2020-00015
• Device Sequence Number: 14097959
• Product Code: MIH
• UDI-Device Identifier: 00733132613687
• UDI-Public: 00733132613687
• 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
• Report Date (Section B): 12/18/2019

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: 11/30/2015
• Device Catalogue Number: TGT3720
• Device Lot Number: 10941618
• 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: 01/08/2020
• 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: 78 YR