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

Model Number	TAC123115A
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications include but are not limited to: hydralizine, dilaudid, clonidine, sennosides, albuterol, amlodipine, arformoterol, carvedilol, novolog, oxycodone, melatonin.Patient medical history includes but is not limited to: copd, t2dm, htn, pad.The instructions for use states, complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to: access, delivery and deployment events (e.G.Access failure; deployment difficulties/failures; failure to deliver the stent graft; and insertion or removal difficulty), neurologic damage, local or systemic (e.G., stroke, paraplegia, paraparesis), 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, this patient underwent emergent endovascular treatment of a zone 2 type b dissection with malperfusion, and was implanted with a gore® tag® thoracic branch endoprosthesis (tbe) with coverage of the left subclavian artery (lsa).Three gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn devices) were implanted as branch devices within the lsa as the appropriately sized side branch devices were not available.Additionally, it was reported that during advancement of the tbe device, the physician encountered alot of difficulty positioning the tbe device to align properly to the greater curve.The tbe device had been withdrawn back down to the descending thoracic aorta at least ten times in an attempt to get the portal to line up; as it kept flipping to the lesser curve of the aorta as opposed to the greater curve.The device was also completely removed from the sheath and reinserted it back into the sheath in hopes of getting it to track and align better.Additionally, it was reported that during all the excessive device manipulation, that the lunderquist wire parked in the ascending thoracic aorta had been dragged back to the level of the descending aorta and had to be re-advanced back up into the ascending aorta.The tbe device was successfully deployed and three viabahn devices were implanted within the lsa.On (b)(6) 2023, (late morning) it was reported that the patient had minor right side stroke symptoms with left sided paralysis.The patient paralysis is reported to have now resolved according to the physician.

• 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: 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16856040
• Report Number: 2017233-2023-03904
• Device Sequence Number: 6564309
• Product Code: MIH
• UDI-Device Identifier: 00733132654178
• UDI-Public: 00733132654178
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/02/2023

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: 01/08/2025
• Device Model Number: TAC123115A
• Device Catalogue Number: TAC123115A
• 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: 04/14/2023
• Initial Report FDA Received Date: 05/02/2023
• Date Device Manufactured: 01/10/2022
• 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: Other; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 52 KG