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

Catalog Number	TGU404010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that these lots met all pre-release specifications.Also was involved tgu404015/14222568; (b)(4).According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to dissection.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.Please note, that medwatch#2017233-2019-00136 was emailed to fda to cover the aneurysm enlargement.
Event or Problem Description
On (b)(6) 2016, the patient was implanted with conformable gore® tag® thoracic endoprostheses to treat a thoracoabdominal aortic aneurysm.The devices were placed in the distal descending thoracic aorta.Patient tolerated the procedure.Reportedly, the pre-treatment computed tomography angiography (cta) showed that the maximum diameter of the aortic aneurysm/lesion was 65mm.It was reported that a dissection originated immediately adjacent below the distal end of the implanted thoracic endograft extending throughout the abdominal aorta into the common iliac arteries bilaterally.The first device (tgu404015/14222568) was deployed at the area of severe tortuosity covering the proximal tear but approximately 5 cm superior to the celiac axis.This deployed nicely.However, the physician wanted to extend this down the celiac access to exclude the dissection, therefore a tgu404010/13263733 was used as a distal extension.The device was placed into the aorta and second angiogram was performed demonstrating the location of the celiac axis again and this was confirmed, and the second device was delivered 1 or 2 cm superior to the celiac access.From (b)(6) 2016 to (b)(6) 2017, the aneurysm diameter decreased in size from 59mm to 43mm.However, on (b)(6) 2018, the follow up cta showed that the maximum diameter of the aortic aneurysm/lesion was 48.6mm.On (b)(6) 2019, the follow up cta showed that the maximum diameter of the aortic aneurysm/lesion was 43mm.On (b)(6) 2019, the aortic and left iliac dissection was identified.Reportedly, the endovascular treatment and an open procedure were not possible due to the significant risk of morbidity and mortality.The physician is monitoring the patient.

• 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: 8414705
• Report Number: 2017233-2019-00135
• Device Sequence Number: 2170125
• Product Code: MIH
• UDI-Device Identifier: 00733132617739
• UDI-Public: 00733132617739
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2019

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: 10/31/2017
• Device Catalogue Number: TGU404010
• Device Lot Number: 13263733
• 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: 03/12/2019
• 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: Other
• Patient Age: 72 YR
• Patient Weight: 87