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

Model Number	TGMR313120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thrombus (2101)
Date of Event	01/15/2020
Type of Reportable Event	Death
Event or Problem Description
Patient implanted with gore® tag® conformable thoracic stent graft with active control system on (b)(6) 2020 for treatment of a thoracic aortic aneurysm.A transcaval access was utilized, and the ctag devices were implanted without issue.An abbott plug was then implanted at the end of the procedure.The patient tolerated the procedure.After the procedure, the patient developed thrombus in the sma and celiac arteries.Thrombolytic therapy was performed, but was ineffective.The patient died on (b)(6) 2020.The physician is unsure of the source of the thrombus, but does not believe it is device related.
Additional Manufacturer Narrative
H6: code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Additional Manufacturer Narrative
H1: type of reportable event - corrected from serious injury to death.
Additional Manufacturer Narrative
Narrative/corrected data - the following device was also implanted: tgm343420/(b)(4).

• 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: 9757096
• Report Number: 2017233-2020-00130
• Device Sequence Number: 2412218
• Product Code: MIH
• UDI-Device Identifier: 00733132646791
• UDI-Public: 00733132646791
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 05/01/2020

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: 05/07/2022
• Device Model Number: TGMR313120
• Device Catalogue Number: TGMR313120
• Device Lot Number: 20947786
• 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; Not provided
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/15/2020; 04/29/2020; 05/04/2020
• 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: Death; Required Intervention
• Patient Age: 67 YR