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

Model Number	TSB080806A
Medical Device Problem Codes	Complete Blockage (1094); Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Aneurysm (1708); Vascular Dissection (3160); Reduced Blood Flow (4598)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the patient underwent endovascular treatment of a zone 2 thoracic aortic aneurysm using gore® tag® thoracic branch endoprostheses (tbe).It was reported that the case was with a side branch into left subclavian artery (lsa).Reportedly, the access and the deployment of the tbe aortic component and tbe side branch tsb080806/26297332 were performed with no reported issues.During the ballooning of the side branch device with a coda balloon, the proximal end of tsb was inflated past vessel profile.A lsa angiography was performed, and a rupture was noticed.According to the physician, the over ballooning caused the vessel rupture.A second side branch (tsb080806/26265891) was inserted to the level of the vertebral artery.The deployment was as expected.Another angio scan was performed, and the rupture was still present.A third side branch (tsb080806/26265890) was deployed covering the vert to the level of the internal mammary artery (ima).The post deployment angiography showed no rupture with good outflow.Post op patient had palpable pulse in the arm and no signs of neuro deficits.Reportedly, 14 hrs post op ( ~4 am), the patient developed numbness in left fingertips.At ~8 am follow up ct confirmed that no flow noticed inside branch.Reportedly, all three devices were occluded due to the outflow issue.On (b)(6) 2023 (pod 3 ), the plan was for an carotid ax bypass which was bumped for an emergency coronary artery bypass graft (cabg).On (b)(6) 2023 (pod 4) the bypass procedure was performed.On (b)(6) 2023 (pod 5) the patients discharged without complication.
Additional Manufacturer Narrative
H6: code c20- a review of the manufacturing record for the devices are going to be conducted.The investigation is in process.The devices remain implanted and are not available for investigation.Also were used: tsb080806a/ 26265891 udi# (b)(4) and tsb080806a/ 26265890 udi# (b)(4).Images were requested.Further information will be provided.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
H6: code c19: a review of the manufacturing records for the devices verified the lots met all pre-release specifications.The devices remain implanted and are not available for analysis.Also were used: tsb080806a/ 26265891 udi#(b)(4) and tsb080806a/ 26265890 udi# (b)(4).B5: the event description was updated.Please note that the patient did not have a cabg procedure on (b)(6) 2023 (pod 3) mentioned in the initial report, it was done for the emergency procedure for another patient.B6: imaging evaluation result was added.According to the physician, the over ballooning caused the vessel rupture.The gore® tag® thoracic branch endoprosthesis instructions for use (ifu) state: after deployment, all device components should be ballooned sequentially if necessary.Ballooning of the side branch component should be performed using an appropriate diameter non-compliant balloon catheter or compliant balloon catheter sized according to the left subclavian artery diameter per the manufacturer¿s instructions for use.Care should be taken when ballooning.To avoid vessel trauma, do not over inflate.Balloon rupture and/or vessel damage may occur.For sb component ballooning, the balloon catheter should be selected according to the left subclavian artery diameter and should have a balloon length no more than 2 cm.Ballooning should be performed first in the region of the portal overlap, followed by ballooning in the branch vessel per the balloon catheter's instructions for use.It is recommended to balloon throughout the length of the sb component.- it is recommended to balloon with a compliant balloon or hand inflate with a non-compliant balloon in the "curved" segment of the sb component.According to the gore® tag® thoracic branch endoprosthesis instructions for use (ifu), possible adverse events and complications that may occur with the use of gore® tag® thoracic branch endoprosthesis include, but are not limited to rupture of the aortic vessel and/or surrounding vasculature, endoprosthesis occlusion and reoperation.
Event or Problem Description
On (b)(6) 2023, the patient underwent endovascular treatment of a zone 2 thoracic aortic aneurysm using gore® tag® thoracic branch endoprostheses (tbe).It was reported that the case was with a side branch into left subclavian artery (lsa).Reportedly, the access and the deployment of the tbe aortic component and tbe side branch tsb080806/26297332 were performed with no reported issues.During the ballooning of the side branch device with a coda balloon, the proximal end of tsb was inflated past vessel profile.A lsa angiography was performed, and a rupture was noticed.According to the physician, the over ballooning caused the vessel rupture (coded: 1400-e:-rupture events - other/unknown).A second side branch (tsb080806/26265891) was inserted to the level of the vertebral artery.The deployment was as expected.Another angio scan was performed, and the rupture was still present.A third side branch (tsb080806/26265890) was deployed covering the vert to the level of the internal mammary artery (ima).The post deployment angiography showed no rupture with good outflow.Post op patient had palpable pulse in the arm and no signs of neuro deficits.Reportedly, 14 hrs post op ( ~4 am), the patient developed numbness in left fingertips.At ~8 am follow up ct confirmed that no flow noticed inside branch.Reportedly, all three devices were occluded due to the outflow issue.On (b)(6) 2023 (pod 4) the bypass procedure was performed.On (b)(6) 2023 (pod 5) the patients discharged without complication.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17094806
• Report Number: 2017233-2023-03991
• Device Sequence Number: 12713392
• Product Code: MIH
• UDI-Device Identifier: 00733132654352
• UDI-Public: 00733132654352
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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): 07/21/2023

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: 07/05/2024
• Device Model Number: TSB080806A
• Device Catalogue Number: TSB080806
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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: Required Intervention; Other; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 67 KG