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

Model Number	TGU343420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2017 a patient underwent treatment of a thoracic aortic aneurysm, zone 0 in the ssb 11-02 study.A conformable gore® tag®thoracic endoprosthesis was utilized in the procedure.On (b)(6) 2021 an endoleak, proximal (reportedly probable type ii) segmental thoracic vessel, with interval increase in the size of the aortic sac occurred.This increase was at the level of the carina the aortic sac has increased from 6.6 x 6.7 cm to 7.3 x 7.3 cm at the level of the inferior left pulmonary vein the aortic sac previously 6.5 x 7 cm now measures 7 x 7.6 cm.On (b)(6) 2021 a reintervention took place to treat the endoleak and the patient did well following the procedure.
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to endoleak and aneurysm enlargement.
Additional Manufacturer Narrative
Change b3- on (b)(6) 2021 a type ib endoleak was revealed, segmental thoracic vessel, with interval increase in the size of the aortic sac occurred.H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.H.6.Conclusion code 1: 22: according to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to endoleak and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2021 a type ib endoleak was revealed, segmental thoracic vessel, with interval increase in the size of the aortic sac occurred.
Additional Manufacturer Narrative
H6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.H.6.Conclusion code 1: 22: according to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to endoleak and aneurysm enlargement.

• 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: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12849282
• Report Number: 2017233-2021-02554
• Device Sequence Number: 17216562
• Product Code: MIH
• UDI-Device Identifier: 00733132618170
• UDI-Public: 00733132618170
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2022

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: 05/07/2020
• Device Model Number: TGU343420
• Device Catalogue Number: TGU343420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 12/22/2021; 01/07/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/06/2022; 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2017
• 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: A
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 88 KG