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

Model Number	TGU404020
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy dates: lopressor 25 mg tablet, allopurinol 300 mg tablet, levocetirizine 5 mg tablet, atorvastatin 40 mg tablet, aspirin ec 81 mg ec tablet.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® thoracic endoprosthesis include, but are not limited to, endoleak, aortic expansion (e.G.Aneurysm), and reoperation.
Event or Problem Description
On (b)(6) 2019 the patient underwent endovascular repair of a thoracic aortic aneurysm without rupture using a conformable gore® tag® thoracic endoprosthesis.During ct follow-up on (b)(6) 2020 a suspected distal type i endoleak was identified.It was noted that a possible type ii endoleak had been being monitored.Aneurysm enlargement was also reported.The aneurysm was reported to have expanded from 6.9cm to 7.1cm.On (b)(6) 2020 a reintervention was performed to treat the suspected distal type i endoleak.The distal type i endoleak was confirmed.Reportedly no type ii endoleak was confirmed or treated.The previously implanted ctag device was extended using a gore® tag® conformable thoracic stent graft with active control system.The distal type i endoleak was successfully treated.There were no further reported issues.The patient tolerated the procedure.

• Brand Name: GORE TAG CONFORMABLE 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
• MDR Report Key: 10172086
• Report Number: 2017233-2020-01004
• Device Sequence Number: 11203125
• Product Code: MIH
• UDI-Device Identifier: 00733132617760
• UDI-Public: 00733132617760
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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: 07/18/2019
• Device Model Number: TGU404020
• Device Catalogue Number: TGU404020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/18/2020
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 94