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

Catalog Number	TGU404015
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As it is unknown what device the endoleak was attributed to, additional devices implanted: tgu404010/(b)(4) and tgu404010/(b)(4) have been listed.According to the conformable gore® tag® thoracic endoprosthesis instructions for use, complications associated with the use of the gore® tag® thoracic endoprosthesis that may occur and/or require intervention include, but are not limited to: endoleak.The review of the manufacturing paperwork verified that these lots met all pre-release specifications.
Event or Problem Description
On (b)(6) 2014, the patient was treated for a thoracic aortic aneurysm using endologix stent graft and conformable gore® tag® thoracic endoprostheses.On an unknown date, imaging identified a type iii endoleak component disconnect between the endologix device and a ctag device (lot number unknown).It was reported the cause of type iii endoleak is unknown.No aneurysm enlargement was reported.On (b)(6) 2018, a reintervention was performed bridging the two devices.The endoleak was reportedly resolved and the patient tolerated the procedure.

• 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: 8238055
• Report Number: 2017233-2019-00019
• Device Sequence Number: 1607594
• Product Code: MIH
• UDI-Device Identifier: 00733132618163
• UDI-Public: 00733132618163
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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: 06/30/2015
• Device Catalogue Number: TGU404015
• Device Lot Number: 10513063
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2019
• 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: 77 YR