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

Catalog Number	TGU343415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the patient underwent endovascular repair of a thoracic aortic dissection in the ascending and descending thoracic aorta.The physician planned to perform an open repair in the ascending aortic arch with an artificial trunk.Then the physician was going to deploy a conformable gore® tag® thoracic endoprosthesis.The physician planned to suture the artificial graft to the conformable gore® tag® thoracic endoprosthesis.It was reported that the physician unintentionally deployed the conformable gore® tag® thoracic endoprosthesis (tgu343415/18748005) in the false lumen.He was able to pull the device out of the false lumen, due to the open repair.The explanted graft was destroyed at the hospital.The physician then implanted a different conformable gore® tag® thoracic endoprosthesis in the true lumen and was able to suture it to the artificial graft.The patient tolerated the procedure.Reportedly on or after (b)(6) 2018, the patient expired due to hyperkalemia which was not caused or contributed by the use of the conformable gore® tag® thoracic endoprosthesis.
Additional Manufacturer Narrative
Addition other relevant history.Addition concomitant medical products.Code 213- the review of the manufacturing paperwork verified that this lot met all pre-release specifications.Code 22- the conformable gore® tag® thoracic endoprosthesis instructions for use states that potential device or procedure related adverse events include endoprosthesis improper placement.

• 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: 8233133
• Report Number: 2017233-2019-00011
• Device Sequence Number: 13925093
• Product Code: MIH
• UDI-Device Identifier: 00733132618156
• UDI-Public: 00733132618156
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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: 10/02/2021
• Device Catalogue Number: TGU343415
• Device Lot Number: 18748005
• 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: 01/10/2019
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLAVIX, AND ELIQUIS
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR