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	TGM454520
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at the time of event/date of birth: asked but unavailable.Patient weight: asked but unavailable.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.Images were provided, and an imaging evaluation was performed.The imaging evaluation found the following: one time-point available for evaluation: pre-implantation cta of the chest and the abdomen.3d images of the chest do not appear to show dissection in the ascending thoracic aorta.The primary aortic entry tear appears to be ~3.8mm distal to the left subclavian artery (lsa).The proximal lsa appears to be dissected.The superior mesenteric artery appears to be dissected.The dissection appears to extend through the common iliac arteries, bilaterally.The dissection appears to extend into the left external iliac artery.The pre-implantation cta images provided do not allow for evaluation in relation to the reported complaint.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, dissection of the aortic vessel & surrounding vasculature.Furthermore, the ifu states that the the gore® tag® conformable thoracic stent graft is intended for endovascular repair of all lesions of the descending thoracic aorta including, but not limited to, type b dissections.The safety and effectiveness of the gore® tag® conformable thoracic stent graft have not been evaluated in patient etiologies including, but not limited to, previous stent or stent graft or previous surgical repair in the descending thoracic aortic area.
Event or Problem Description
On (b)(6) 2021 the patient underwent open treatment of a thoracic aortic dissection whereby a gore® tag® conformable thoracic stent graft with active control system (ctag a/c) was delivered antegrade into the patient's ascending aorta following aortic arch debranching.After deployment of the ctag a/c device, the treatment site was confirmed using a transesophageal echocardiogram (tee) probe.There were no reported issues.It was reported that approximately an hour and 20 minutes later the physicians were preparing to close.Reportedly a tee probe was used again to verify the treatment site prior to closure.It was reported that a type a dissection was observed.Reportedly the entry tear was unable to be observed.The dissection was described as a delayed tear and there was no suspected cause for how or why the tear appeared.The physicians re-opened the site.A piece of felt was sewn to a section of the graft and a section of the dissection in order to bridge the area.The dissection was resolved.There were no further reported issues.The patient tolerated the procedure.

• 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: 12013724
• Report Number: 2017233-2021-02086
• Device Sequence Number: 16943135
• Product Code: MIH
• UDI-Device Identifier: 00733132647002
• UDI-Public: 00733132647002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2021

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: 03/11/2022
• Device Model Number: TGM454520
• Device Catalogue Number: TGM454520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/16/2021
• 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