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	TGMR404020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	06/21/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The following additional devices were investigated as it is not known which device, if any, caused or contributed to the patient death: according to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: respiratory failure, embolization and death.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2021 a patient was undergoing treatment of an ascending aortic aneurysm as a subject in the ssb 1102 clinical study.The procedure included the use of four gore® tag® conformable thoracic stent grafts with active control system.A gore® dryseal flex introducer sheath was used for access.During the procedure a series of adverse events occurred which led to eventual intraprocedural death.The physician stated the following: ¿in summary, i believe she suffered a series of stresses that cumulatively resulted in her arrest when she became hypoxemic during the reintubation event.The series of stressed included the intermittent hypotension from the wire, treated with pressors for several hours.Her left pelvis/leg were ischemic for about 3.5 hours.The difficulty establishing distal seal in the dta, the left femoral cut-down all caused prolongation of the operation.She had an acute bleed from the access site complication, which although immediately recognized and treated was yet another hit.After all these events, i suspect that her hypoxemia exhausted her physiologic reserve and she coded.The device performed as anticipated and there were no evident technical complications with the device that i am aware of.I believe this was a procedure related event and not a device related event.We are awaiting the autopsy results to determine if there is any alternative explanation for her code and to assess her brain for stroke.Given the acuity from any event and her death, i am unsure if the autopsy will be revealing for stroke.¿ the physician also stated the access injury was not related to the gore sheath.
Additional Manufacturer Narrative
H.6.Results code 1: 213: a review of the manufacturing records for the devices verified the lots met all pre-release specifications.D.10.The following additional devices were investigated: tgmr404020 udi: (b)(4) sn# (b)(6).Tgm454515 udi: (b)(4) sn# (b)(6).Tgmr404020 udi: (b)(4) sn# (b)(6).
Additional Manufacturer Narrative
Additional information from study center indicated that the devices were not responsible for patient death.The previous report is hereby retracted.

• 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: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12132541
• Report Number: 2017233-2021-02143
• Device Sequence Number: 4180238
• Product Code: MIH
• UDI-Device Identifier: 00733132646852
• UDI-Public: 00733132646852
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2022

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: 02/17/2024
• Device Model Number: TGMR404020
• Device Catalogue Number: TGMR404020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 10/25/2021; 06/08/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 10/25/2021; 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H.10./11.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 70 KG