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

Model Number	TGMR373720
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic Dissection (2491)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2020, the patient was treated for an aortic dissection.The physician implanted two conformable gore® tag® thoracic endoprostheses.The procedure was successful and the patient tolerated the procedure.On (b)(6) 2020, the patient presented emergently with a retrograde type i dissection.
Event or Problem Description
On, (b)(6) 2020, the patient underwent endovascular treatment of a thoracic aortic dissection with gore® tag® thoracic endoprostheses.The procedure concluded with the successful repair of the dissection and the patient was reported to have tolerated the procedure.It was reported, post-operatively on (b)(6), 2020, the patient presented with malperfusion and was reported to have suffered a stroke (details unknown).Reported evidence of a retrograde dissection proximal (outside of treatment area) to the previously implanted tag device and a new entry tear originating at the aortic root were identified.The cause of the dissection is reportedly unknown, however, the physician stated the new dissection is unrelated to the original dissection treated in (b)(6) 2020, and there were no reported issues with the implanted tag® devices.On (b)(6)2020, an open surgical repair was performed to treat the new dissection.According to the report the dissection was successfully repaired and the patient was reported doing well after the procedure.
Additional Manufacturer Narrative
Upon receipt of additional information this event has been determined to be non-reportable as all dissection conditions noted under md24757, page 9, have not been met.The physician reported the gore® devices did not cause or contribute to the new dissection or the patient¿s post-implant symptoms of stroke and malperfusion.It was reported the patient presented with a new dissection, outside of the previous treatment area.As there is no medical evidence to suggest the gore® tag® thoracic branch endoprostheses caused, or may have caused or contributed to a serious injury to this patient, medwatch (mfr.Report # 2017233-2020-00444), is being retracted.

• 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: 10174078
• Report Number: 2017233-2020-00444
• Device Sequence Number: 19503364
• Product Code: MIH
• UDI-Device Identifier: 00733132646821
• UDI-Public: 00733132646821
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/26/2020

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: 09/07/2022
• Device Model Number: TGMR373720
• Device Catalogue Number: TGMR373720
• Device Lot Number: 21237896
• 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: 06/19/2020
• Supplement Report FDA Received Date: 09/08/2020
• 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: 41 YR