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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/01/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Medications: dilaudid, tylenol, synthroid, and oxycodone.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis that may occur and/or require intervention include, but are not limited to fistula and death.
Event or Problem Description
The following information was reported to gore through the pivotal study for the gore® tag® thoracic branch endoprosthesis (tbe device): on (b)(6) 2017, pre-implantation imaging identified an ascending thoracic aortic dissection (zone 0) with a reported total treatment length of 32.6 cm.Additionally, significant thrombus was identified at the distal implantation site.On (b)(6) 2017, the patient underwent successful revascularization of the head vessels, consisting of right carotid to left carotid and left carotid to left subclavian artery bypass procedures.On (b)(6) 2017, the patient underwent endovascular treatment of the thoracic dissection, proximal to the brachiocephalic trunk and distal to the sinotubular junction, with two gore® tag® thoracic branch endoprostheses (tac123720c/16282141 and tsb121506c/14424573) and a conformable gore® tag® thoracic endoprosthesis (tgu454520/16449009).It was reported that on (b)(6) 2018, the patient presented with a possible aortopulmonary fistula.Then had an acute pulmonary hemorrhage and expired.

• 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: 8060267
• Report Number: 2017233-2018-00674
• Device Sequence Number: 2745420
• Product Code: MIH
• UDI-Device Identifier: 00733132617753
• UDI-Public: 00733132617753
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2018

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: 06/07/2020
• Device Catalogue Number: TGU454520
• Device Lot Number: 16449009
• 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: 11/12/2018
• 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; Hospitalization; Life Threatening
• Patient Age: 61 YR
• Patient Weight: 96