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	TGMR313120
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The fsa reported: on (b)(6) 2021, the patient was implanted with a gore® tag® conformable thoracic stent graft with active control system.The patient was being treated with an open procedure and for a ruptured transverse arch descending thoracic aorta.Reportedly the patient had a previous procedure (date of procedure is unknown) with a homograft that was already implanted.Due to the patient status, there was cpr being performed while the physician was attempting to work on the thoracic aorta rupture.It was reported that the physician was attempting to insert the gore® tag® conformable thoracic stent graft with active control system antegrade, with no guidewire and no fluoroscopy.While attempting to deploy the device, the first and second step was done successfully.Upon attempting to release the handle, the wire was not attached, and the device was not deployed but inside the patient.The physician removed the undeployed device by hand.The device was destroyed at the hospital.A different gore® tag® conformable thoracic stent graft with active control system device was used and deployed successfully.The patient expired during the procedure.The cause of death was not attributed to the gore device or procedure but due to problems associated with cpr and the homograft.No further event information is available.Patient weight, comorbidities and medications is not available and the hospital would not release this information.
Additional Manufacturer Narrative
Addition the gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the following: no device or images of the device were returned for evaluation.A potential root cause for the lockwire not being attached to the handle could not be confirmed since the device was not returned.During testing for design validation, process qualification, and ongoing quality control testing, devices are tested in anatomical models¿ representative of cmds indicated use.There is potential that off-label use in an antegrade fashion may have contributed to the reported event.Addition health effect - impact code.Addition investigation findings.Addition investigation conclusions.

• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12853519
• Report Number: 2017233-2021-02557
• Device Sequence Number: 3808176
• Product Code: MIH
• UDI-Device Identifier: 00733132646791
• UDI-Public: 00733132646791
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: PO40043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2023
• Device Model Number: TGMR313120
• Device Catalogue Number: TGMR313120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 01/06/2022
• Date Device Manufactured: 10/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female