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	Component Incompatible (1108)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® tag® thoracic endoprosthesis instructions for use (ifu) complications associated with the use of the may include but are not limited to: endoleak, reoperation.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
On (b)(6) 2020, this patient underwent treatment for a descending thoracic aortic aneurysm and was implanted with gore® tag® conformable thoracic stent graft with active control system.The patient tolerated the procedure.On (b)(6) 2020, the patient underwent reintervention for treatment of a proximal type i endoleak and was implanted with an additional gore® tag® conformable thoracic stent graft with active control system.The treatment plan was to extend seal and coverage proximally to the left common carotid artery(lcca).The device was loaded onto the lunderquist wire and advanced to the aortic arch without issue and advanced proximal to target landing zone, and then repositioned to target deployment location.The first stage of deployment was completed; the string was fully removed and the device opened to 50% proximally for the first 2cm then was constrained and then opened up again distally.The second stage deployment was then completed successfully, but the mid segment of the graft still did not open up.Neuromonitoring said pressures had then dropped in the femorals, so an angio was done to show the constrained segment of the graft.A gore® tri-lobe balloon catheter was inserted into the graft and ballooned successfully distally, then was inserted into the compressed segment successfully and ballooned with a pop, the fabric opened to full diameter.Neuromonitoring stated everything went back to baseline at that point.Additional ballooning was then done throughout the length of the graft to make sure it was fully apposed to the previously place graft, as well as proximally to try to get rid of a bird beak that was present on the inner curve.Throughout the ballooning process, the graft had lost 3-4mm of proximal seal off of the lcca.The proximal type 1 endoleak was decreased but still patent.The physicians chose to conclude the procedure and follow up with computed tomography angiography.
Additional Manufacturer Narrative
Further investigation determined there was no allegation of deficiency associated with the device in this case.Wherefore, this device was reported in error and the medwatch 2017233-2020-01401 previously submitted is hereby retracted.
Additional Manufacturer Narrative
Corrected back to code 22: according to the gore® tag® thoracic endoprosthesis instructions for use (ifu) complications associated with the use of the may include but are not limited to: endoprosthesis: incomplete deployment;.

• 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
• MDR Report Key: 10772559
• Report Number: 2017233-2020-01401
• Device Sequence Number: 1679597
• Product Code: MIH
• UDI-Device Identifier: 00733132646852
• UDI-Public: 00733132646852
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2021

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: 10/16/2022
• Device Model Number: TGMR404020
• Device Catalogue Number: TGMR404020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/08/2020; 10/08/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 11/06/2020; 06/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 79 YR