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

Model Number	TGU373715
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event also includes device 13785188/ 00733132618187.
Event or Problem Description
The following information was reported to gore through the global registry for endovascular aortic treatment (great 10-11): on (b)(6) 2015 the patient underwent endovascular repair of a descending thoracic aortic aneurysm using two conformable gore® tag® thoracic endoprostheses.The maximum diameter of the aneurysm measured 60 mm.The patient tolerated the procedure.On (b)(6) 2016 coil embolization was performed to treat a persistent endoleak of unknown type.The patient tolerated the procedure.

• Brand Name: CONFORMABLE GORE TAGTHORACIC 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
• MDR Report Key: 12319522
• Report Number: 2017233-2021-02259
• Device Sequence Number: 4713304
• Product Code: MIH
• UDI-Device Identifier: 00733132618187
• UDI-Public: 00733132618187
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 08/13/2021

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: 03/31/2018
• Device Model Number: TGU373715
• Device Catalogue Number: TGU373715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 123