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

Catalog Number TGU343420J

Device Problem No Apparent Adverse Event (3189)

Patient Problems Aneurysm (1708); No Code Available (3191)

Event Date 02/06/2018

Event Type  Injury  

Manufacturer Narrative

Tgu343420j/14855596 (b)(4).It is unknown which of the two implanted devices were involved in the reported type ii endoleak.The device information of the additional device is: tgu404020j/12375982 (b)(4).According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoleak, aneurysm enlargement and surgical conversion.Users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.As the date of event (aneurysm enlargement due to the type ii endoleak) is unknown, the date of event will be used as (b)(6) 2018 - the date of surgery.

Event Description

On (b)(6) 2016, this patient underwent an endovascular procedure to repair a thoracic aortic aneurysm using two conformable gore® tag® thoracic endoprostheses.Prior to the procedure, a total arch replacement with an "elephant trunk technique" was performed, and the proximal portion of the endoprostheses was implanted inside the surgical graft (elephant trunk).The procedure was concluded with no reported issue.The patient tolerated the procedure.On an unknown date, follow-up imaging showed an aneurysm enlargement with unknown amount due to a type ii endoleak.On (b)(6) 2018, an open surgery was performed to repair the aneurysm enlargement due to the type ii endoleak.During the procedure, it was reportedly confirmed that the origin of the endoleak was the bronchial artery.The endoprostheses were explanted, and a surgical graft was utilized.The proximal end of the graft was anastomosed to the pre-existing surgical graft (elephant trunk), and the distal end of the graft was anastomosed to a native aorta.The patient reportedly tolerated the procedure and is doing well.

• Brand Name: CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7307098
• MDR Text Key: 101308661
• Report Number: 2017233-2018-00140
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2019
• Device Catalogue Number: TGU343420J
• Device Lot Number: 14855596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR