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

Model Number	TGU343410
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Aneurysm (1708); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Also was implanted tgu343420/ 14262103 (b)(4).The devices remain implanted and are not available for investigation.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), endoleak and reoperation.(b)(4).
Event or Problem Description
On (b)(6) 2016 a patient underwent a treatment of a thoracoabdominal aortic aneurysm zone 3, with two conformable gore® tag® thoracic endoprostheses.Chimney technique was used with branch vessel treatment of the celiac, superior mesenteric and right renal arteries.The brand of stents used in the branch vessels is unknown.The maximum aortic diameter in the treatment zone was 68mm by cta.The follow up cta showed that on (b)(6) 2016 the maximum aortic diameter in the treatment zone was 60.1mm.From (b)(6) 2017 till (b)(b) 2018 the maximum aortic diameter in the treatment zone increased in size from 62mm to 64mm.It was reported that on (b)(6) 2022, the follow up cta showed that the maximum aortic diameter was 89mm.Reportedly, on (b)(6) 2022, a gutter type iii endoleak related to the ¿snorkel¿ procedure of the superior mesenteric artery (sma) was noticed.Due to the information provided, the endoleak was attributed to the gore® tag® thoracic endoprostheses.There was a poor seal along the stent used for the snorkel.The physician did not notice any component disconnection or tear/disruption in the graft material.On (b)(6) 2022, the patient underwent the coil embolization procedure of the aortic stent graft endoleak.The patient tolerated the procedure.

• Brand Name: CONFORMABLE GORE® TAG®THORACIC 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
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14366568
• Report Number: 2017233-2022-02918
• Device Sequence Number: 2046602
• Product Code: MIH
• UDI-Device Identifier: 00733132617807
• UDI-Public: 00733132617807
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

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: 12/20/2018
• Device Model Number: TGU343410
• Device Catalogue Number: TGU343410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/11/2022
• Date Device Manufactured: 12/21/2015
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 66 KG