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

Model Number	TGMR404010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a gore® tag® conformable thoracic stent graft with active control system on (b)(6) 2020 to treat a thoracic aortic aneurysm.On (b)(6) 2020, the patient was implanted with a gore® excluder® aaa endoprosthesis.The patient tolerated the procedure.Additional information from the fsa stated that the reintervention was performed to treat further malperfusion.Per the physician, it was unrelated to the ctag device.
Additional Manufacturer Narrative
H6: code 3331 a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: code 213 the review of the manufacturing paperwork verified that this lot met all pre-release specifications.H6: code 67 no problem detected.

• 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: 10040851
• Report Number: 2017233-2020-00350
• Device Sequence Number: 2956482
• Product Code: MIH
• UDI-Device Identifier: 00733132646838
• UDI-Public: 00733132646838
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/13/2020

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: 12/10/2022
• Device Model Number: TGMR404010
• Device Catalogue Number: TGMR404010
• Device Lot Number: 21746544
• 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: 05/08/2020
• Supplement Report FDA Received Date: 05/21/2020
• 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: 60 YR