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

Model Number	TGU343415
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, this patient underwent endovascular repair of an abdominal aortic aneurysm using three conformable gore® tag® thoracic endoprostheses.On (b)(6) 2019, a distal type i endoleak was identified on follow up.There was no aneurysm enlargement.The cause of the endoleak was disease progression along with ¿bird beaking¿ at the distal end of the device.The device did not take the curve of the aorta, therefore contributing to the endoleak.On (b)(6) 2019, a reintervention occurred whereby two gore® tag® thoracic endoprostheses with active control were implanted.The endoleak was resolved.
Additional Manufacturer Narrative
H10/11: additional manufacturer narrative/corrected data - a4: patient weight.B7: patient comorbidities, medications.

• 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: 9403037
• Report Number: 2017233-2019-01203
• Device Sequence Number: 16951856
• Product Code: MIH
• UDI-Device Identifier: 00733132618156
• UDI-Public: 00733132618156
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 03/12/2021
• Device Model Number: TGU343415
• Device Catalogue Number: TGU343415
• Device Lot Number: 17952617
• 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: 12/03/2019
• Supplement Report FDA Received Date: 01/21/2020
• 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: Other; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 59