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

Catalog Number	TSB081506A
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, patient underwent an endovascular procedure to treat a zone-2 aneurysm utilizing gore® tag® thoracic branch endoprosthesis.On (b)(6) 2024, physician sent over a ct scan to the fsa, which showed an endoleak.The ct scan was dated on (b)(6) 2024.On (b)(6) 2024, during a follow-up visit, a type iii endoleak near the portal and aneurysm enlargement (unknown amount) was seen on ct imaging.Physician recommends reintervention surgery to treat this endoleak.On (b)(6) 2024, a reintervention surgery was performed.Physician ballooned the portal.An angiogram was performed, and no endoleak was observed.Patient tolerated the procedure.The cause of the endoleak remains unknown.
Additional Manufacturer Narrative
H6: code c20 - the device remains implanted and, therefore, was not available for direct analysis by gore.Patient medical history and medication include the following: medical history: aaa, anemia, blood clots, high cholesterol, high blood pressure, kidney disorder, acute kidney failure.Medication: eliquis, prednisone, metoprolol succinate, methotrexate sodium, levothyroxine sodium, hydrochlorothiazide, folic acid, fluoxetine, cyanocobalamin, allopurinol, acetaminophen and aspirin.It should be noted that, per the gore® tag® thoracic branch endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to, endoleak.Images were provided.The following was reported by gore imaging: the imaging evaluation performed by a clinical imaging specialist showed the following: ¿ one time-point available for evaluation: post-implantation cta dated (b)(6) 2024.¿ axial images show contrast outside the proximal implanted devices.¿ an endoleak is confirmed or unknown origin.¿ the lsa diameters appear to range from ~11.8mm ¿ 12.7mm.Diameters are within device sizing range.¿ proximal landing zone diameters: aortic diameter 2cm proximal to the lsa distal border appears to be ~43mm ¿ 45.8mm.Aortic diameter ~1cm proximal to the lsa distal border appears to be 43.0mm.Aortic diameter at the distal lsa border appears to be ~41.8mm ¿ 44.7mm.Majority of aortic diameters appear to be outside of chosen device range.Cannot confirm a type i endoleak with available images.Possible gutter leak.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
Updated section g3/g4, h6, and h10.H6: code c19-a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.As the device was not accessible, the product history review (phr) review was the extend of the investigation.No device problem was found per review of these records.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• 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: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20380370
• Report Number: 2017233-2024-05378
• Device Sequence Number: 9628327
• Product Code: MIH
• UDI-Device Identifier: 00733132654383
• UDI-Public: 00733132654383
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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: 01/29/2026
• Device Catalogue Number: TSB081506A
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/06/2024
• Supplement Report FDA Received Date: 10/15/2024
• 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: Required Intervention
• Patient Sex: Male
• Patient Weight: 88 KG