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

Catalog Number	TGU373710
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/25/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.According to the gore® tag® thoracic endoprostheses instructions for use, potential adverse events that may occur and/or lead to intervention include aneurysm rupture and death.
Event or Problem Description
On (b)(6) 2014, this patient underwent endovascular repair of a thoracoabdominal aortic aneurysm using gore® tag® thoracic endoprostheses.On (b)(6) 2016, a procedure occurred whereby a gore® viabahn® endoprosthesis was implanted in the superior mesenteric artery to extend a previously implanted graft (unknown manufacturer).On (b)(6) 2019, computed tomography imaging showed an unstable type ii endoleak at the level of the mid/distal thoracic aorta, with evidence of rupture of the aneurysm and bleeding into the left pleural space.After discussion with the patient about endovascular repair vs open repair vs comfort measures, the patient elected for palliative care consult and to pursue comfort measures.The patient expired on (b)(6) 2019.

• 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: 8695861
• Report Number: 2017233-2019-00420
• Device Sequence Number: 1888922
• Product Code: MIH
• UDI-Device Identifier: 00733132617722
• UDI-Public: 00733132617722
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

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: 10/31/2016
• Device Catalogue Number: TGU373710
• Device Lot Number: 12052114
• 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: 06/13/2019
• 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: Death
• Patient Age: 87 YR
• Patient Weight: 66