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

Model Number	TGU262110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, the patient was implanted with conformable gore® tag® thoracic endoprosthesis to treat an intramural hematoma.It was reported the left anterior oblique images during implant were poor due to the patient¿s morbid obesity.The final imaging run revealed sluggish flow through the left subclavian artery.The physician used a fogarty catheter to make sure there were no clots in the left subclavian artery.On (b)(6) 2019, the patient had complaints of left arm pain.A computed tomography (ct) revealed that a portion of the conformable gore® tag® thoracic endoprosthesis was partially covering the left subclavian artery.The physician reintervened and implanted a gore® viabahn® vbx expandable endoprosthesis in the ostium of the subclavian artery and ballooned the area.The patient tolerated the reintervention.
Additional Manufacturer Narrative
Addition h6: code 213-the review of the manufacturing paperwork verified that this lot met all pre-release specifications.Addition h6: code 22-per the gore® tag® thoracic endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoprosthesis: improper placement.

• 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: 9625105
• Report Number: 2017233-2020-00052
• Device Sequence Number: 11460832
• Product Code: MIH
• UDI-Device Identifier: 00733132617791
• UDI-Public: 00733132617791
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/21/2020

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: 10/21/2021
• Device Model Number: TGU262110
• Device Catalogue Number: TGU262110
• Device Lot Number: 20019137
• 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: 01/23/2020
• Supplement Report FDA Received Date: 02/21/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 129