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	TGMR404020
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #tgmr404015/ serial #(b)(4)/ udi #(b)(4).Catalog #tgmr404010/ serial #(b)(4)/ udi #(b)(4).Patient weight: asked but unavailable.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.
Event or Problem Description
On (b)(6) 2020 the patient underwent endovascular treatment of a thoracic aortic aneurysm using three gore® tag® conformable thoracic stent grafts with active control system.Upon ct follow-up approximately 4 weeks after the original procedure it was reported that contrast was observed in the aneurysm sac with aneurysm sac enlargement.It was reported that on (b)(6) 2020 the patient underwent reintervention of a type iii endoleak between two of the gore® tag® conformable thoracic stent grafts with active control system (ctag a/c).It is reportedly unclear which devices were involved with the type iii endoleak.Reportedly the proximal end of the most proximal ctag a/c device, placed near the patient's aortic arch, did not have full circumferential apposition, and it was suspected that this may have contributed to the type iii endoleak.It was reported that the area where the type iii endoleak occurred was relined with an additional tgm454515 gore® tag® conformable thoracic stent graft with active control system.There were no further reported issues.The patient tolerated the reintervention.
Additional Manufacturer Narrative
H.6.Conclusions code 2: code 22 - according to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to, endoleak, aortic expansion (e.G.Aneurysm), and reoperation.

• 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
• MDR Report Key: 10819421
• Report Number: 2017233-2020-01439
• Device Sequence Number: 4123743
• Product Code: MIH
• UDI-Device Identifier: 00733132646852
• UDI-Public: 00733132646852
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: 02/13/2023
• Device Model Number: TGMR404020
• Device Catalogue Number: TGMR404020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/07/2020
• 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: 60 YR