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

Catalog Number TGU262610J

Device Problem Compatibility Problem (2960)

Patient Problem Vascular Dissection (3160)

Event Date 10/24/2018

Event Type  Injury  

Manufacturer Narrative

According to the conformable gore® tag® thoracic endoprosthesis instructions for use, complications associated with the use of the gore® tag® thoracic endoprosthesis that may occur and/or require intervention include, but are not limited to dissection.

Event Description

On (b)(6) 2018, the patient underwent treatment of an acute stanford type b dissection with conformable gore tag® thoracic endoprostheses.Prior to the tevar, ax-ax bypass was performed.A tgu262610j was implanted distally and a tgu313115j was implanted proximally.On (b)(6) 2018, a distal stent graft induced new entry (d-sine) was identified distal to the tgu262610j.The false lumen was enlarged due to the new entry.The abdominal branch vessels were almost occluded due the false lumen.In order to treat the new entry, a tgu262110j was implanted distal to the tgu262610j.After the tgu2622110j was implanted, a junction type iii endoleak was observed between the tgu262110j and the tgu262610j.Ballooning was reportedly performed to treat the type iii endoleak.The type iii endoleak was diminished, but remained.The patient tolerated the procedure.

Manufacturer Narrative

Code 213 ¿ the review of the manufacturing paperwork verified that the lots met all pre-release specifications.According to the conformable gore® tag® thoracic endoprosthesis instructions for use, complications associated with the use of the gore® tag® thoracic endoprosthesis that may occur and/or require intervention include, but are not limited to dissection.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8078956
• MDR Text Key: 127405659
• Report Number: 2017233-2018-00700
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/01/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2021
• Device Catalogue Number: TGU262610J
• Device Lot Number: 17982875
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR