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

Model Number	TAC124015A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, the patient was treated for a thoracic aortic aneurysm.While attempting to insert a gore® tag® thoracic branch endoprosthesis and 24fr dryseal sheath into the patient's external iliac artery, the physician experienced difficulty advancing, resulting in a dissection of the right external iliac.The devices were removed, and the dissection was repaired with a viabahn.The physician then tried to use a smaller device/sheath combination, and was successfully able to complete the procedure.The gore® tag® thoracic branch endoprosthesis and dryseal sheath will be returned for evaluation.
Additional Manufacturer Narrative
H.6.Type of investigation code b21 updated to code b01 and b14 with completion of phr review and returned product evaluation.H.6.Investigation findings: code c21 updated to code c19 with completion of phr review and returned product evaluation.H.6.Investigation conclusions: code d16 updated to code d1101 with completion of returned product evaluation.· the gore tag thoracic branch endoprosthesis (tbe) device evaluation for (b)(4) showed the following: o the event description stating ¿the physician decided to remove the tbe device back through the sheath but struggled to get the device back through the sheath¿ is consistent with what was found during the device evaluation.O per the manufacturing product history review (phr), (b)(4), a review of the manufacturing records indicated that the manufacturing lot met all pre-release specifications.O the event description states, ¿the plan was to implant a (b)(6) (26fr sheath on label) but the physician chose to insert the device through a 24fr sheath due to the small access¿.Per the tbe instructions for use (ifu), a 12x40x15 aortic component should be used with a 26fr sheath.O the root cause cannot be confirmed; however, the use of the 12x40x15 device with a 24fr sheath is potentially a contributing factor to the reported event of difficulty getting the device back through the sheath.O no manufacturing deficiencies associated with the tbe aortic component were identified during the device evaluation.
Additional Manufacturer Narrative
Additional investigation determined no product problem or deficiency caused or contributed to an adverse event/incident for the patient; the initial medwatch and any supplemental report submitted under manufacturer report number 2017233-2023-04111 was submitted in error and is hereby retracted.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17333429
• Report Number: 2017233-2023-04111
• Device Sequence Number: 6647515
• Product Code: MIH
• UDI-Device Identifier: 00733132654239
• UDI-Public: 00733132654239
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2023

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: 02/11/2026
• Device Model Number: TAC124015A
• Device Catalogue Number: TAC124015A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 06/22/2023; 06/22/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 10/02/2023; 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• 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: 72 YR
• Patient Sex: Female