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

Catalog Number	TGU454515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic Dissection (2491)
Date of Event	10/02/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 death.
Event or Problem Description
On (b)(6) 2018, the patient was implanted with an gore® excluder® aaa endoprosthesis and a conformable gore® tag® thoracic endoprostheses to treat a thoracic aortic dissection.The patient had tortuous anatomy.It was reported that prior to the implant of the conformable gore® tag® (tgu454515/(b)(4)), the patient had a bovine arch and the physician bypassed the right carotid artery to the left carotid artery and then to the left subclavian artery (lsa).The physician plugged the lsa and ligated the left carotid vertebral artery coming off the aortic arch.The physician confirmed through angiograph that the circle of willis was intact and the bypasses were patent.The physician then implanted a gore® contralateral leg endoprosthesis (plc21000/(b)(4)) into the innominate artery as a snorkel graft.The physician implanted the conformable gore® tag® (tgu454515/(b)(4)), by access through the brachiocephalic artery.While attempting to implant a second conformable gore® tag® (tgu454515/(b)(4)), there was difficulty getting the guidewire from the innominate artery into the ascending aorta.The guidewire would continue to be pulled out of the ascending aorta into the transverse aorta.The physician attempted for over an hour to get the guidewire into position to deliver the conformable gore® tag® device into deployment location.The conformable gore® tag® (tgu454515/(b)(4)) was not implanted in this case.The physician chose to abort the case and monitor the patient.The patient was stable and all grafts were patent.The physician did not want to perform an open repair due to a previous sternotomy.The patient was extubated later that evening.On (b)(6) 2018, the patient became bradycardic and coded.The patient expired.Due to family not wanting an autopsy, the cause of death is unknown.

• 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: 8026938
• Report Number: 2017233-2018-00658
• Device Sequence Number: 1640655
• Product Code: MIH
• UDI-Device Identifier: 00733132618200
• UDI-Public: 00733132618200
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2018

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: 07/18/2020
• Device Catalogue Number: TGU454515
• Device Lot Number: 16605635
• 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: 10/31/2018
• 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; Life Threatening
• Patient Age: 58 YR
• Patient Weight: 113