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

Catalog Number	TGM343420
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #tac082815a/ serial #(b)(6)/ udi (b)(4) which is captured in manufacturer report #2017233-2023-04237.D.10.Concomitant medical products and therapy dates: amlodipine, asa, atorvastatin, folic acid, hydrochlorothiazide, metoprolol, potassium chloride.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, the patient underwent endovascular treatment of a type b thoracic aortic dissection with an aneurysmal component using zone 2 placement of a gore® tag® thoracic branch endoprosthesis (tbe) aortic component and distal extension using a gore® tag® conformable thoracic stent graft with active control system (ctag a/c).It was noted that the aortic arch had a double bend.It was reported that the tbe device was well placed with the portal at the distal edge of the patient's left subclavian artery (lsa).The proximal end of the device was still 2-3 cm from the patient's left common carotid artery (lcca).No ballooning was performed since this was for treatment of a type b dissection, and it was reported that no proximal extension was performed as it did not appear necessary.It was reported that the ctag a/c device was placed distally and ended in the mid-descending thoracic aorta so as to limit aortic coverage.The dissection extended to the celiac artery.Final angiograms showed continued filling of the false lumen creating a type ib dissection.The physician chose to watch and wait.On or around (b)(6) 2023, follow-up cta imaging showed continued filling of the false lumen beside the graft with aneurysm expansion from 6 cm to 7 cm.The physician suspected a distal type i endoleak and probable proximal type i endoleak.Reintervention was performed on (b)(6) 2023.The proximal type i endoleak was reportedly not visualized on angiogram, but the tbe aortic component was extended proximally using a tbe te2840 aortic extender component.The distal type i endoleak was visualized and treated with distal extension of the ctag a/c using an additional ctag a/c device (tgm343415).The endoleaks were successfully excluded.There were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H6: investigation conclusions: code d12 added.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use, potential adverse events or complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to, aortic expansion (e.G., aneurysm, false lumen, landing zone, lesion), endoleak, and reoperation.H6: investigation findings for analysis of production records: code c21 updated to code c19.H6: investigation conclusions: code d16 updated to code d15.
Additional Manufacturer Narrative
H.6.Investigation conclusions: code d15 and d12 remain unchanged b.3.Date of event corrected.B.3.Date of event: as continued filling of the false lumen was observed during the index procedure on (b)(6) 2023, the date of event has been updated to 09-jun-2023.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17635714
• Report Number: 2017233-2023-04238
• Device Sequence Number: 6473775
• Product Code: MIH
• UDI-Device Identifier: 00733132646975
• UDI-Public: 00733132646975
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• 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,Followup,Followup
• Report Date (Section B): 01/02/2024

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: 03/01/2026
• Device Catalogue Number: TGM343420
• 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: 08/01/2023
• Supplement Date Received by Manufacturer: 09/06/2023; 01/02/2024
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/18/2023; 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 FOR LIST OF MEDICATIONS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 102 KG