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 #18427747/ udi # (b)(4) which is captured in manufacturer report #2017233-2019-00998.Concomitant medical products- patient medications: valium, neurontin, lexapro, oxycodone, azulfidine, tylenol, lipitor, plavix, deltasone.
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: 9169950
• Report Number: 2017233-2019-00999
• Device Sequence Number: 1801335
• 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
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: TGU454520
• Device Lot Number: 18427742
• 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