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

Model Number	TGMR404020
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Code	Aortic Dissection (2491)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the instructions for use (ifu) for the gore® tag® conformable thoracic stent graft with active control system; adverse events that may occur include, but are not limited to: stent graft migration or realignment.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
On (b)(6) 2020, this patient underwent an endovascular treatment for a thoracic aortic dissection and was implanted with a gore® tag® conformable thoracic stent graft with active control system.The patient tolerated the procedure.On (b)(6) 2020, the patient underwent follow-up computed tomography (ct) which showed the device had migrated distally approximately 1 cm.The physician attributes the migration to remodeling of the true lumen and plans to re-intervene at a later date.
Additional Manufacturer Narrative
Event : additional/corrected information.
Event or Problem Description
On an unknown date estimated to be on or about (b)(6) 2020 the patient underwent re-intervention and a medtronic navien graft was placed to treat the migration and extend coverage.Patient was treated successfully according to physician.
Additional Manufacturer Narrative
Images were provided to gore for evaluation and showed the following: the images received cannot be used to perform a full imaging evaluation because they do not meet the dicom standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the images provided for review.Gore cannot make conclusions or guarantee the images provided are complete, accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.Images received via (email) with no patient identifier or date of acquisition in image.Three jpg images received, arterial phase only ct images.There appears to be a contrast-like density outside of the implanted graft, contrast cannot be confirmed with the available image set.Unable to confirm migration with the available image set.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10040718
• Report Number: 2017233-2020-00349
• Device Sequence Number: 2956481
• Product Code: MIH
• UDI-Device Identifier: 00733132646852
• UDI-Public: 00733132646852
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 06/12/2020

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: 03/26/2022
• Device Model Number: TGMR404020
• Device Catalogue Number: TGMR404020
• Device Lot Number: 20729795
• 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; Not provided
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 05/20/2020; 06/12/2020
• 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: Hospitalization; Other
• Patient Age: 45 YR