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	03/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Medications: dilaudid, tylenol, synthroid, and oxycodone.
Event or Problem Description
The following information was reported to gore through the (b)(6) 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).Follow up images dated (b)(6) 2017, revealed an infected fem-fem bypass graft.The graft was explanted.The patient tolerated the procedure.It was reported that on (b)(6) 2017 the patient presented with bacteremia.On (b)(6) 2018, the patient presented with a chronically infected aortic graft.Required inpatient hospitalization or prolongation of existing hospitalization.
Event or Problem Description
On (b)(6), 2018, the patient presented with a chronically infected aortic graft.Required inpatient hospitalization or prolongation of existing hospitalization.Drug therapy was used to treat the infection, the patient was discharged on (b)(6), 2018.
Additional Manufacturer Narrative
Addition: b5.Addition: a review of the sterilization records for the device verified that the lot met all pre-release specifications.Addition h6: code 22-the conformable gore® tag® thoracic endoprosthesis instructions for use states that potential device or procedure related adverse events include infection (e.G., aneurysm, device).

• 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: 8061520
• Report Number: 2017233-2018-00676
• Device Sequence Number: 16673832
• 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,Followup
• Report Date (Section B): 12/18/2018

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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/18/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 96