MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TGU454520
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: item #tgu454520/ lot #18427742/ udi (b)(4).Concomitant medical products- patient medications: valium, neurontin, lexapro, oxycodone, azulfidine, tylenol, lipitor, plavix, deltasone.The device remains implanted, so evaluation of the actual device was unable to be completed.Images were provided, and an imaging evaluation was performed.The review of the manufacturing paperwork verified that the lot met all pre-release specifications.The imaging evaluation stated the following: one time-point available for evaluation- post implantation cta dated (b))(6) 2019.The length from the left subclavian artery (lsa) to the proximal circumferential device appears to be 2.4cm by outer curve length.Aortic diameter just distal to the lsa appears to be 42mm.Aortic diameter at the level of the proximal circumferential device appears to be 41mm.There appears to be contrast outside the proximal implanted device.Mip image appears to show 6 gold bands, therefore illustrating 3 devices implanted.There appears to be a proximal and distal 20cm device, as well as a 15cm device in the middle.There appears to be lack of device/aortic wall apposition at the distal end of the distal device.Aortic diameter appears to be 53mm.There appears to be contrast outside the distal implanted device.Imaging appears to demonstrate a proximal and distal type i endoleak.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® thoracic endoprosthesis include, but are not limited to, endoleak and reoperation.It was reported that visualization for device placement using the c-arm angle was not optimal, therefore contributing to the devices being placed slightly short of the intended landing zone both proximally and distally where the endoleaks were later identified.
Event or Problem Description
On (b)(6) 2019 the patient underwent endovascular repair of a thoracic aortic aneurysm using conformable gore® tag® thoracic endoprostheses.It was noted that, due to the c-arm angle at the time of device implant, visualization for placement using the c-arm angle was not optimal.Reportedly the devices were placed slightly short of the intended landing zone both proximally and distally.On (b)(6) 2019 a computed tomography scan was performed.Reportedly a proximal type i endoleak was noted on the proximal tgu454520 conformable gore® tag® thoracic device, and a distal type i endoleak was noted on the distal tgu454520 conformable gore® tag® thoracic device.No aneurysm enlargement was noted.On (b)(6) 2019 a reintervention was performed to treat the endoleaks.It was reported that the previously implanted conformable gore® tag® thoracic devices were extended proximally and distally using two tgm454510 gore® tag® conformable thoracic stent grafts with active control system.There were no further reported issues.The patient tolerated the procedure.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9169945
• Report Number: 2017233-2019-00998
• Device Sequence Number: 2615206
• Product Code: MIH
• UDI-Device Identifier: 00733132617753
• UDI-Public: 00733132617753
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: TGU454520
• Device Lot Number: 18427747
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2019
• 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: 77 YR
• Patient Weight: 82