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

Model Number TAC123115A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Vascular Dissection (3160)

Event Date 04/14/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 314414331
• Report Number: 2017233-2023-03904
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132654178
• UDI-Public: 00733132654178
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: TAC123115A
• Device Catalogue Number: TAC123115A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 05/02/2023
• Date Device Manufactured: 01/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 52 KG