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

Catalog Number	TGU404020
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: item # tgu454510/ lot # 13763200/ udi # (b)(4).Item # tgu454520/ lot # 12750635/ udi # (b)(4).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.
Event or Problem Description
The following information was reported using an ide (b)(4) emergency use report for the gore® ascending stent graft device: on (b)(6) 2015 the patient underwent endovascular repair of a thoracic aortic aneurysm using a conformable gore® tag® thoracic endoprosthesis.In (b)(6) 2015 the patient presented with hypertensive emergency, and a dissecting descending aortic aneurysm.On (b)(6) 2015 the patient underwent endovascular repair of the descending thoracic aorta using two additional conformable gore® tag® thoracic endoprostheses to treat the dissecting aortic aneurysm.On (b)(6) 2019 the patient presented with hemoptysis.A computed tomography angiography revealed areas with extra aortic fluid collection.A pseudoaneurysm was suspected.On (b)(6) 2019 a pseudoaneurysm arising from the vein graft site in the ascending aorta was confirmed during surgical workup.The patient was admitted to an outside hospital with lower extremity weakness, nausea, vomiting and diarrhea.The patient was transferred to the university of pennsylvania hospital for further management due to suspected worsening of a type iii endoleak, and suspected pseudoaneurysm growth.On (b)(6) 2019 the patient underwent ascending aortic thoracic endografting, and relining of the proximal segment of the previously implanted thoracic endograft.A 45mm by 8cm gore® ascending stent graft was implanted, along with a 45mm by 20cm conformable gore® tag® thoracic endoprosthesis.Upon completion of the procedure there was no evidence of an endoleak.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: 8640849
• Report Number: 2017233-2019-00372
• Device Sequence Number: 1644038
• Product Code: MIH
• UDI-Device Identifier: 00733132617760
• UDI-Public: 00733132617760
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/29/2019

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: 09/30/2015
• Device Catalogue Number: TGU404020
• Device Lot Number: 10834272
• 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: 05/24/2019
• 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: 83 YR
• Patient Weight: 53