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

Model Number	TGU373715
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/26/2019
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 conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to aneurysm enlargements.
Event or Problem Description
The following information was reported to gore: on a (b)(6) 2018 patient underwent treatment of a thoracic aortic aneurysm, unknown diameter, zone 2, with two gore® tag® thoracic branch endoprostheses and one conformable gore® tag® thoracic endoprostheses as distal extension to aortic component.According to the report all devices were positioned and implanted without issue.On (b)(6) 2018 a ct revealed the maximum false lumen diameter was 48.2mm.On (b)(6) 2019 the maximum false lumen diameter was 53.2mm.On (b)(6) 2020 persistent false lumen perfusion was reported.A reintervention is planned.
Additional Manufacturer Narrative
B.5.Updated.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 patient underwent treatment of a thoracic aortic dissection, unknown maximum aortic diameter, zone 2, with two gore® tag® thoracic branch endoprostheses and one conformable gore® tag® thoracic endoprostheses as distal extension to aortic component.According to the report all devices were positioned and implanted without issue.On (b)(6) 2018 a ct revealed a type ii endoleak.The maximum aortic diameter was 59.1mm.On (b)(6) 2018 a reintervention occurred whereby a second ctag device was implanted and several embolization plugs were placed in the false lumen.On (b)(6) 2018 a ct revealed the maximum false lumen diameter was 48.2mm.On (b)(6) 2019 the maximum false lumen diameter was 53.2mm.On (b)(6) 2020 persistent false lumen perfusion was reported.This false lumen perfusion was reportedly coming from the same area as the previous incidence.A reintervention is planned to take place when status has calmed down.The event is ongoing.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10084640
• Report Number: 2017233-2020-00382
• Device Sequence Number: 2861685
• Product Code: MIH
• UDI-Device Identifier: 00733132618187
• UDI-Public: 00733132618187
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 04/29/2021
• Device Model Number: TGU373715
• Device Catalogue Number: TGU373715
• Device Lot Number: 18126691
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2020
• Supplement Report FDA Received Date: 06/09/2020
• 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: Other
• Patient Age: 64 YR
• Patient Weight: 103