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

Model Number	TGMR373710
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 a thoracic dissection was treated by means of a left carotid subclavian bypass and implantation of a conformable gore® tag® thoracic endoprosthesis proximal to a previously placed ctag.On (b)(6) 2021 x-ray examination revealed a wire fracture at the proximal end of the device.
Additional Manufacturer Narrative
B.5.Updated.H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2021 a patient underwent stage 1 treatment for an abdominal aortic aneurysm in the (b)(6) clinical trial.A conformable gore® tag® thoracic endoprosthesis (ctag) was implanted.On (b)(6) 2021 a type b aortic dissection was observed.On (b)(6) 2021 the dissection was treated by means of a left carotid subclavian bypass and implantation of a conformable gore® tag® thoracic endoprosthesis proximal to the originally placed ctag.Dissection captured in case (b)(4).On (b)(6) 2021 x-ray examination revealed a wire fracture at the proximal end of the device.
Additional Manufacturer Narrative
H.6.Results code 2: 3252: imaging evaluation summary: there appears to be a wire fracture present.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• 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: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12573609
• Report Number: 2017233-2021-02437
• Device Sequence Number: 10993958
• Product Code: MIH
• UDI-Device Identifier: 00733132646807
• UDI-Public: 00733132646807
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2023
• Device Model Number: TGMR373710
• Device Catalogue Number: TGMR373710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/04/2021; 11/24/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/29/2021; 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2020
• 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
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 48 KG