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

Catalog Number	TGU343410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications: amlodipine, aspirin, atorvastatin, and levothyroxine.(b)(4).
Event or Problem Description
On (b)(6) 2018, the patient was implanted with conformable gore® tag® thoracic endoprostheses to treat a new chronic thoracic aortic dissection proximal to the existing implanted devices, not in the previously treated area of the aorta.Prior to this procedure on (b)(6) 2012, the patient was implanted with three gore® tag® thoracic endoprostheses to treat a chronic dissection.On (b)(6) 2017, the patient was implanted with gore® excluder® aaa endoprostheses in the abdominal aorta, gore® viabahn® endoprostheses were implanted in bilateral renal arteries, the celiac artery and superior mesenteric artery as ¿chimneys¿ to treat a new chronic dissection.In addition, on an unknown date, the patient had bare metal stents implanted in both femoral arteries.It was reported access was made through the right femoral artery and that after deploying the conformable gore® tag® thoracic endoprosthesis (tgu343410/18359270) on (b)(6) 2018, the proximal end of the device partially opened, approximately 30% open, down to the first 1 cm of the device.The rest of the device fully opened.The physician attempted to balloon the device and it remained partially open.A gore® excluder® contralateral leg endoprosthesis was implanted inside the implanted conformable gore® tag® thoracic endoprostheses to use as radial force to ensure the device remained open and patent.The patient tolerated the procedure.The physician and field sales associate examined the deployment line and the delivery catheter, both were intact with no defects.The delivery catheter was destroyed at the hospital.
Additional Manufacturer Narrative
Correction adverse event or product problem.

• 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: 7840470
• Report Number: 2017233-2018-00532
• Device Sequence Number: 1468924
• Product Code: MIH
• UDI-Device Identifier: 00733132617807
• UDI-Public: 00733132617807
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/19/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2021
• Device Catalogue Number: TGU343410
• Device Lot Number: 18359270
• 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: 09/01/2018
• Supplement Report FDA Received Date: 10/19/2018
• 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: 79 YR
• Patient Weight: 62