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

Model Number	TGT2810
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Clinical Endoleak (4843)
Date of Event	06/14/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2011, the patient underwent an endovascular treatment of a retrograde type a dissection and ulp using three gore® tag® thoracic endoprostheses.After all devices were implanted, a proximal type i endoleak was observed.The physician decided to monitor this endoleak.On an unknown date, a follow-up exam revealed the proximal type i endoleak and the false lumen enlargement.No new entry tear was found in false lumen.It was unknown if there was persistent false lumen perfusion.On (b)(6) 2023, a reintervention was performed.A gore® tag® conformable thoracic stent graft with active control system was implanted proximally.The endoleak was resolved.In addition, it was also reported that physician did not report additional information on cause of the type 1 endoleak and the false lumen enlargement occurred due to the type 1 endoleak.
Additional Manufacturer Narrative
H6: code e2121-used to capture false lumen enlargement.H6: code c21 - results pending completion of product history review.H6: code c20 - the device remains implanted and, therefore, was not available for direct analysis by gore.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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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.
Additional Manufacturer Narrative
H6: code c19-a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.As the device was not accessible, the product history review (phr) review was the extend of the investigation.No device problem was found per review of these records.It should be noted that, per the gore® tag® thoracic endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to, endoleaks.

• Brand Name: GORE® TAG® THORACIC ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17171259
• Report Number: 2017233-2023-04044
• Device Sequence Number: 7154715
• Product Code: MIH
• UDI-Device Identifier: 00733132613595
• UDI-Public: 00733132613595
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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: 10/31/2013
• Device Model Number: TGT2810
• Device Catalogue Number: TGT2810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female