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

Catalog Number	TGU404010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: (b)(4).
Event or Problem Description
On (b)(6) 2019, the patient underwent endovascular repair of an abdominal aortic aneurysm using conformable gore® tag® thoracic (ctag) endoprostheses, gore® excluder® aaa (excluder) endoprostheses, and gore® viabahn® vbx balloon expandable (vbx) endoprostheses.Images (date and modality) reveal a possible unknown endoleak or a ¿possible gutter¿ (between which devices is unknown).There is aneurysm sac enlargement, amount is unknown.It was reported that on (b)(6) 2019, there was a reintervention.The physician extended the superior mesenteric artery (sma) with a gore® viabahn® vbx balloon expandable (vbx) endoprostheses and then placed a 40 mm conformable gore® tag® thoracic endoprosthesis.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition h6: code 213-the review of the manufacturing paperwork verified that these lots met all pre-release specifications.Addition h6: code 22-according to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis that may occur and/or require intervention include, but are not limited to aneurysm expansion and reoperation.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9218828
• Report Number: 2017233-2019-01070
• Device Sequence Number: 11318691
• Product Code: MIH
• UDI-Device Identifier: 00733132617739
• UDI-Public: 00733132617739
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/03/2019

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: 10/31/2021
• Device Catalogue Number: TGU404010
• Device Lot Number: 20029254
• 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: 10/22/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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; Required Intervention
• Patient Age: 69 YR