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	TGMR373720
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medical history includes but is not limited to: thoracic dissection, coronary artery disease, hyperlipidemia and svt.Concomitant medical products:: patient medications include but are not limited to: tylenol, albuterol, amiodarone and melatonin.(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.
Event or Problem Description
On (b)(6) 2020, this patient underwent treatment of a type b thoracic dissection and was implanted with gore® tag® conformable thoracic stent grafts.The patient tolerated the procedure.On (b)(6) 2022, the physician reported degeneration of the proximal seal of the most proximal gore® tag® conformable thoracic stent graft, and an extension of the dissection proximally on the inner curve at the level of the left subclavian artery (lsa).The physician believes the extension of the dissection was caused/related to the anastamosis in the arch area near the lsa.On (b)(6) 2022, the patient underwent reintervention and the extension of the dissection gore® tag® thoracic branch endoprostheses.The patient tolerated the procedure with great results.
Additional Manufacturer Narrative
Images were provided to gore for evaluation and showed the following: the aortic diameter just distal to the lsa appears to be 34.6mm.There is a tear ~15mm ¿ 16.7mm proximal to the distal border of the lsa.This finding is consistent with the description summary.The proximal tear is on the inner curve.The false lumen is being perfused from the tear on the inner curve and communicates with contrast on the outer curve.The dissection extends to the celiac artery/end of scan.
Additional Manufacturer Narrative
H6: corrected conclusion code.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15322611
• Report Number: 2017233-2022-03277
• Device Sequence Number: 5518009
• Product Code: MIH
• UDI-Device Identifier: 00733132646821
• UDI-Public: 00733132646821
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2022

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: 11/03/2022
• Device Model Number: TGMR373720
• Device Catalogue Number: TGMR373720
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 08/12/2022; 08/12/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/08/2022; 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• 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: Hospitalization; Required Intervention; Other
• Patient Sex: Male
• Patient Weight: 102 KG