MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGMR313120
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/20/2022
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2022 a patient was admitted for tevar of a dissection.As reported on (b)(6) 2022, the patient passed.Reportedly, the cause of death was determined to be retrograde type a dissection.According to the physician, the patient was suffering from hypertension and that may have led to the retrograde dissection.Confirmation of the original graft placement as well as if the retrograde dissection originated immediately adjacent to the previously implanted device was requested.As reported the physician could not confirm the exact location of the tear for the retrograde type a dissection.
Additional Manufacturer Narrative
The following information has been requested from the treating facility and has not been made available to date: patient name, gender, date of birth, medications, comorbidities (above and beyond htn, which was indicated in the event description.) (b)(4).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.
Additional Manufacturer Narrative
The following medical information was provided.Past medical history: abnormal pap smear, allergy, anxiety state, aortic aneurysm, aortic dissection distal to left subclavian, bipolar disorder, cerebral aneurysm, cerebral artery occlusion with cerebral infarction, cholelithiasis, contusion, heart disease, herniation of invertebral disc between l4 and l5, history of hysterectomy, hypertension, lumbar disc herniation, ovarian cyst, pyelonephritis, tia (transient ischemic attack).Past surgical history: cesarean section, cholecystectomy, dental surgery, hysterectomy, neck surgery, perforated uterus, pr bypass graft other (carot-subcl), pr drainage of hematoma/fluid, tubal ligation.Medications: atorvastatin (lipitor), buspirone (buspar), clonidine hcl (catapres), enalapril (vasotec), hydrocodone acetaminophen (norco), labetalol (normodyne), naloxone actuation spray, non-formulary hair skin nails supplement, omeprazole (prilosec), sucralfate (carafate), sumatriptan (imitrex) section a.Added the following patient information: patient identifier, gender, date of birth, age at the time of the event, and weight b2.Added date of death as confirmed in medical records.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), potential adverse events/complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to: dissection of the aortic vessel and surrounding vasculature, and death.B5.Updated description summary in b5 with additional/corrected information received from the treating facility.G3/g4.Date received by manufacturer updated to october 21, 2022 as medical records and additional/corrected information was received on this date and have since been reviewed.
Event or Problem Description
As reported, on (b)(6), 2022 a patient was admitted for tevar.Provided medical records indicate a descending thoracic aortic aneurysm and indicate the tevar included a left subclavian bypass.As reported, on (b)(6), 2022, the patient passed.Reportedly, the cause of death was determined to be retrograde type a dissection.According to the physician, the patient was suffering from hypertension and that may have led to the retrograde dissection.As reported, the physician could not confirm the exact location of the tear for the retrograde type a dissection.Provided medical records indicate that it extended proximal to the tevar and involved all intermediary vessels.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15649975
• Report Number: 2017233-2022-03418
• Device Sequence Number: 14029242
• Product Code: MIH
• UDI-Device Identifier: 00733132646791
• UDI-Public: 00733132646791
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 11/16/2022

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: 07/20/2024
• Device Model Number: TGMR313120
• Device Catalogue Number: TGMR313120
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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: Death; Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 74 KG