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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: tgu454510/14820255 and tgu373710/14491031.(b)(4).(b)(6).
Event or Problem Description
On (b)(6) 2016, the patient underwent endovascular repair of a thoracic aortic aneurysm using a conformable gore® tag® thoracic endoprostheses.It was reported that on (b)(6) 2018, the patient presented with hemolysis.A type iii endoleak with component separation was identified.There was excessive overlap between the original implanted conformable gore® tag® thoracic endoprostheses (tgu373710/12562071 and tgu373710/14491031) and therefore the tgu454510/14820255 disconnected from both implanted devices.The physician reintervened and bridged the component disconnection by implanting a conformable gore® tag® thoracic endoprosthesis (tgu454520/18712623).The patient tolerated the procedure.

• 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: 8192249
• Report Number: 2017233-2018-00793
• Device Sequence Number: 11237878
• Product Code: MIH
• UDI-Device Identifier: 00733132617722
• UDI-Public: 00733132617722
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2018

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: 03/31/2017
• Device Catalogue Number: TGU373710
• Device Lot Number: 12562071
• 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: 12/21/2018
• 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: 84 YR
• Patient Weight: 67