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

Catalog Number	TAC084015A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code b20 ¿ the device remains implanted and, therefore, was not available for direct analysis by gore.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 branch endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to, endoleak.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) 2023, patient underwent an endovascular procedure to treat a zone-2 type-b thoracic dissection utilizing gore® tag® thoracic branch endoprosthesis.On (b)(6) 2024, during a ct scan, a type 1a endoleak was observed.On (b)(6) 2024, patient underwent a reintervention surgery to treat this type 1a endoleak.On 9/5/2024, fsa became aware of this reintervention surgery.Physician placed multiple penumbra coils behind the graft out towards the transverse arch.Endoleak was resolved.Patient tolerated the procedure.The cause of the endoleak remains unknown, and no further patient information is currently available.
Additional Manufacturer Narrative
Patient images were provided.The following was reported: two time-points available for evaluation: pre-implantation cta dated (b)(6)2023 and post-implantation cta dated (b)(6)2023.Pre-implantation imaging shows: -patient presents with a bovine arch.-covered length: -the length from the distal border of the lsa to the distal border of the brachiocephalic (bca)/lcca appears to be ~31mm, by outer curve length.-the inner curve length appears to be ~4mm.-diameters appear to range from ~39mm ¿ 48.0mm.Segment length: the length from the distal border of the lsa to the mid origin border of the bca/lcca appears to be ~37.9mm, by outer curve length.The inner curve length appears to be ~7.3mm.Diameters appear to range from ~38.3mm ¿ 48.0mm.Patient presents with a highly angulated thoracic aortic arch.Post-implantation imaging shows: -there is contrast outside the proximal end of the implanted devices.-reconstruction image shows lack of proximal device wall apposition in the thoracic aortic arch.This is commonly referred to as ¿bird-beeking¿.-axial imaging shows contrast outside the proximal implanted devices.The contrast poolings appear to communicate thereby, confirming a proximal type i endoleak.

• 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: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20351299
• Report Number: 2017233-2024-05368
• Device Sequence Number: 8062432
• Product Code: MIH
• UDI-Device Identifier: 00733132654130
• UDI-Public: 00733132654130
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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: 12/07/2025
• Device Catalogue Number: TAC084015A
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2022
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male