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

Catalog Number	TE4043A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Type of investigation: code b22: results pending completion of investigation.Investigation findings: code c21: results pending completion of investigation.Investigation conclusions: d16: conclusion not yet available.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.
Event or Problem Description
On (b)(6) 2024, the patient was treated for a zone 2 thoracic aortic dissection.The physician implanted a gore® tag® thoracic branch endoprosthesis aortic component tac084020a, two gore® tag® thoracic branch endoprostheses side branches, (tsb081506a), and a gore® tag® thoracic branch endoprosthesis aortic extender te4043a.The patient tolerated the procedure.On a follow up visit, imaging revealed a dissection proximal to the te4043a.The physician believes the damage is too extensive for endovascular repair, and is planning an open conversion.Images were returned for evaluation.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, and h3 h3: the device was not returned to gore for direct analysis.However, images were provided.According to the imaging evaluation: the imaging evaluation performed by a clinical imaging specialist showed the following: four time-points available for evaluation: pre-implantation abd/pelvis cta dated (b)(6) 2023, pre-implantation chest cta dated (b)(6) 2023, post-implantation chest/abd cta dated (b)(6) 2024, and post-implantation chest cta dated (b)(6) 2024.Pre-implantation abd/pelvis cta dated (b)(6) 2023 show there to be imh vs.Thrombus in the distal descending thoracic aorta (dta).An aortic tear cannot be identified on this time-point or else a false lumen would also be a possibility that the blue mask is representing.The pre-implantation chest cta dated (b)(6) 2023 shows the same ¿grainy¿ appearing thrombus vs.Imh in the dta.Aortic diameter at the level of the distal lsa border appears to be 40.8mm.Aortic diameter 1cm distal to the lsa appears to be 45.5mm.Aortic diameter 2cm distal to the lsa appears to be ~53mm.Post-implantation cta dated (b)(6) 2024 shows blue masking in the ascending thoracic aorta (ata).Radiopaque markers on the images show 2 ctag devices and one aortic extender are implanted.Post-implantation cta dated (b)(6) 2024 shows the same blue masking in the ata represents false lumen.On this image set, an aortic tear can be identified in the ata.The tear is ~3.2cm proximal to the brachiocephalic artery, by outer curve length.
Additional Manufacturer Narrative
Investigation findings: code c21 updated to code c19.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: investigation conclusions: code d16 updated to d15 and d12: according to the gore® tag® thoracic endoprosthesis instructions for use (ifu) complications associated with the use of the may include but are not limited to: dissection, perforation, or rupture of the aortic vessel and/or surrounding vasculature.

• Brand Name: GORE® TAG® THORACIC BRANCH 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86001 ; 9285263030
• MDR Report Key: 19188321
• Report Number: 2017233-2024-04872
• Device Sequence Number: 7694231
• Product Code: MIH
• UDI-Device Identifier: 00733132654338
• UDI-Public: 00733132654338
• Combination Product (Y/N): N
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2024

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: 03/23/2024
• Device Catalogue Number: TE4043A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 05/24/2024; 05/24/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/24/2024; 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male