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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications: flomax, xanax, and labetalol.Ct images dated (b)(6) 2019, were sent to gore imaging services for evaluation.Per the evaluation the very proximal edge of the implanted device can be visualized at the level of the brachiocephalic distal border.The length from the brachiocephalic artery to the lsa distal border appears to be ~3.2cm, by outer curve length.There appears to be contrast in the false lumen that possibly communicates with contrast in the lsa.There appears to be a possible fenestration/tear ~7.6cm distal to the distal end of the implanted ctag® device.(b)(4).
Event or Problem Description
On (b)(6) 2019, the patient was implanted with conformable gore® tag® thoracic endoprostheses to treat a type b aortic dissection.It was reported that computed tomography (ct) images (date unknown), revealed a distal type i endoleak with aneurysm sac enlargement (amount is unknown).On (b)(6) 2019, the physician reintervened and implanted two conformable gore® tag® thoracic endoprostheses and extended proximally and distally.The endoleak was resolved and the patient tolerated the reintervention.
Additional Manufacturer Narrative
Correction b3.Correction ct images dated (b)(6), 2019, were sent to gore imaging services for evaluation.Per the evaluation the very proximal edge of the implanted device can be visualized at the level of the brachiocephalic distal border.The length from the brachiocephalic artery to the lsa distal border appears to be ~3.2cm, by outer curve length.There appears to be contrast in the false lumen that possibly communicates with contrast in the lsa.There appears to be a possible fenestration/tear ~7.6cm distal to the distal end of the implanted ctag® device.

• 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: 9462372
• Report Number: 2017233-2019-01245
• Device Sequence Number: 14228876
• Product Code: MIH
• UDI-Device Identifier: 00733132618156
• UDI-Public: 00733132618156
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/06/2020

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: 05/28/2022
• Device Model Number: TGU343415
• Device Catalogue Number: TGU343415
• Device Lot Number: 20778597
• 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: 12/12/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10/11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 93