MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGU454520
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); No Code Available (3191)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note: as it is unknown which gore® tag® thoracic endoprosthesis may have contributed to the reported type i endoleak, an additional gore® tag® device (tgu454520/14194596) will be included in this report.Patient medications include alfuzosin, allopurinol, amlodipine, ascorbic acid (vitamin c), benazepril, cholecalciferol, glucosamine chondroitin, ipratropium, multivitamin, pravastatin, and warfarin sodium.(b)(4).A review of the manufacturing records for the devices verified that the lots met all pre-release specifications.Imaging evaluation findings (ct images dated (b)(6) 2020): there appears to be contrast outside the proximal portion of the endograft in the arterial and delayed phases.Unable to visualize this contrast communicating with the larger, more distal 9cm aneurysm.The previously implanted ctag graft appears to lack apposition to the aorta¿s inner curve.Image cross hairs indicate the position where the graft has complete apposition.Note in the sagittal view the presence of a small vessel which can be demonstrated communicating with the vessel irregularity just distal to the lsa.This does not rule out a type 1 endoleak.The available images do seem to indicate the presence of a type 2 endoleak.Images show small vessels which appear to be communicating with the outpouching/irregularity near the proximally implanted endograft.There appears to be more contrast in the delayed phase in the small outpouching/irregularity near the proximal portion of the endograft.Distal to the outpouching/irregularity there appears to be approx.1cm where the endograft appears to contain complete aortic wall apposition prior to the distal aneurism.No contrast appears to be visualized outside the endograft in this location.Within the distal implantation zone, the implanted endograft appears well apposed to the aorta with no contrast visualized outside the endograft.It should be noted the gore® tag® thoracic endoprosthesis instruction for use (ifu) states ¿complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to endoleak, aortic expansion, and reoperation.Additionally, users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.
Event or Problem Description
On (b)(6) 2015, the patient was implanted with two conformable gore® tag® thoracic endoprostheses to treat a thoracic aortic aneurysm.On (b)(6) 2020, computed tomography (ct) scan reportedly identified a proximal type i endoleak.According to the report, the aneurysm had enlarged to a measurement of 9cm in diameter (original measurement is unknown).On (b)(6) 2020, a re-intervention procedure was performed whereby an additional gore® tag® device was implanted to extend the stent graft system proximally and treat the type i endoleak.The endoleak was resolved and the patient tolerated the procedure.

• Brand Name: CONFORMABLE GORE TAGTHORACIC 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
• MDR Report Key: 10885751
• Report Number: 2017233-2020-01477
• Device Sequence Number: 11570816
• Product Code: MIH
• UDI-Device Identifier: 00733132617753
• UDI-Public: 00733132617753
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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: 09/07/2018
• Device Model Number: TGU454520
• Device Catalogue Number: TGU454520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 79