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

Model Number	TSB081006A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Crushing Injury (1797)
Date of Event	05/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B7: patient medical history includes but is not limited to hypertension, tobacco use.D10: patient medications include but are not limited to: asa 81mg q day, losartan 25mg q day.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 endovascular treatment for a traumatic aortic injury to the left subclavian artery (lsa) due to a fall on her arm and shoulder a week previous.The patient was implanted with gore® tag® thoracic branch endoprostheses.It was noted that the patient had bovine arch.It was reported that the procedure went smoothly and according to plan; all delivery devices were removed intact; all wires, catheters, sheaths were removed intact; vessel closure devices were utilized for 24f sheath access site; with manual pressure was held on lt brachial arm access site.During the time pressure was being held and anesthesia was waking the patient up, the patient went into distress.Compressions were begun and a transesophageal echocardiogram (tee) was performed wherein it was discovered that the patient had a type a dissection (which had not been present before the case had begun).Compressions were continued and as the thoracic surgeon was getting ready to open the chest to put the patient on bypass; the surgeon encountered difficulty getting the trocars placed.Compressions continued and it was noted that the patient¿s stomach started distending incredibly fast.The stomach was opened and a perforation was seen in the iliac artery.Life saving measures were continued but the patient subsequently passed away.The physician stated the patient had a hemorrhagic event down in the iliac arteries and stated he believes this was the cause of death for the patient.The physician does not believe the hemorrhagic event was caused by the gore devices or associated with the treatment to the thoracic aorta.Physician also stated the patient¿s vessels felt different.The patient was confirmed to have not had marfans disease; but the physician suspected some sort of vascular disease as ¿the vessels felt different¿.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17153914
• Report Number: 2017233-2023-04036
• Device Sequence Number: 14426392
• Product Code: MIH
• UDI-Device Identifier: 00733132654369
• UDI-Public: 00733132654369
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: 01/29/2026
• Device Model Number: TSB081006A
• Device Catalogue Number: TSB081006A
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: 05/29/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 63 KG