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

Catalog Number	TAC083115A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Paraplegia (2448); Vascular Dissection (3160)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.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
The following was reported to gore: on (b)(6), 2023, the patient underwent a branched endograft procedure starting from the left subclavian artery (zone 2) to the level of 10th thoracic vertebrae (t10) with the distal end of gore® tag® conformable thoracic stent graft with active control system approximately 6cm above the celiac artery to treat a type b thoracic dissection utilizing a gore® tag® thoracic branch endoprosthesis (branch aortic component), gore® tag® thoracic branch endoprosthesis (side branch) and gore® tag® conformable thoracic stent graft with active control system (ctag ac).Reportedly, the procedure went well with all devices being implanted with no issues and patient tolerated the procedure.Due to the procedure going from the left subclavian artery to the thoracic vertebrae (t10), field sales associate (fsa) recommended a spinal drain before the procedure but physician decided it was not necessary.Later that night, after 10 hours from the procedure, when patient was in the icu, patient developed numbness in feet from the umbilicus to bilateral feet (developed bilateral paralysis).Patient notified the nurse, at which point the doctor stopped the heparin and the patient had 1/5 strength in bilateral lower extremity, no sensation and was unable to move their lower extremity.Anesthesiologist was consulted and a spinal drain was done, after which, the patient is feeling better with full sensation from the umbilical to both bilateral legs.Has full 5/5 strength in right lower extremity but only 1/5 strength in left extremity.Physician indicated there was no problem with the procedure or implanting of the devices to treat the type b thoracic dissection and the issue was due to not putting in the spinal drain that led to loss of sensation in the legs.Patient is being monitored for the loss of strength in the left extremity.Additional information provided on patient's status on (b)(6), 2023: the patient's spinal drain remained in the day after the event, and has gained full sensation and strength back in their left extremity as of (b)(6), 2023 and patient was discharged fully intact and able to walk out of the hospital on their own.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h6.H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.According to the gore® tag® thoracic branch endoprosthesis instructions for use (ifu), possible adverse events and complications that may occur and/or require intervention include, but are not limited to neurologic damage, local or systemic (e.G., stroke, paraplegia, paraparesis) and reoperation.

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17736644
• Report Number: 2017233-2023-04272
• Device Sequence Number: 5472573
• Product Code: MIH
• UDI-Device Identifier: 00733132654079
• UDI-Public: 00733132654079
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 10/03/2023

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: 08/23/2024
• Device Catalogue Number: TAC083115A
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 86 KG