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

Catalog Number	TGM282815
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to stent graft migration or realignment.
Event or Problem Description
On (b)(6) 2019, the patient underwent treatment of an abdominal aortic aneurysm with a gore® tag® conformable thoracic stent graft with active control to treat a thoracic aortic aneurysm.The patient reportedly has very tortuous anatomy and had a coarctation of the aorta that was repaired when he was a child.It was reported the conformable gore® tag® endoprosthesis (tgm282815/20729844) was deployed with the proximal edge of the device distal to the carotid artery.After deployment the final angiogram showed the implanted device had taken the outer curve of the aneurysm sac and had migrated approximately 4mm distally of the intended landing site.The physician was fine with the position and finished the procedure.The patient tolerated the procedure.On (b)(6) 2019, the physician took discharge images and noticed the conformable tag® endoprosthesis had further migrated an additional (13mm) now 17mm from the intended landing zone.The aneurysm sac had thrombosed over and there was no adverse event to the patient.The physician is taking a wait and watch approach since there is no injury or adverse event to the patient.
Additional Manufacturer Narrative
Correction b5.
Event or Problem Description
On (b)(6), 2019, the patient was implanted with a gore® tag® conformable thoracic stent graft with active control to treat a thoracic aortic aneurysm.

• 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: 8862403
• Report Number: 3007284313-2019-00240
• Device Sequence Number: 18986849
• Product Code: MIH
• UDI-Device Identifier: 00733132646944
• UDI-Public: 00733132646944
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 10/08/2019

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: 12/13/2021
• Device Catalogue Number: TGM282815
• Device Lot Number: 20729844
• 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: 08/05/2019
• Supplement Report FDA Received Date: 10/08/2019
• 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
• Patient Age: 43 YR
• Patient Weight: 82