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 Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Vascular Dissection (3160)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: additional device: tgu404020, lot # 11415976, udi: (b)(4).A review of the manufacturing records for the devices verified the lots met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2014 a patient was undergoing treatment of a descending thoracic aortic aneurysm measuring 78.0mm with two conformable gore® tag® thoracic endoprostheses.On (b)(6) 2015 the aneurysm measured 60.5mm.On (b)(6) 2016 the aneurysm measured 62.7mm.On (b)(6) 2018 the aneurysm measured 77.5mm.On (b)(6) 2018 the patient exhibited a type a dissection.An aortic valve replacement, ascending aorta replacement, total arch replacement and descending aorta replacement with removal of implants was performed.The patient tolerated the procedure, but the post-operative course was described as complicated.On (b)(6) 2018 the patient expired.
Additional Manufacturer Narrative
Device code 1 updated.
Additional Manufacturer Narrative
Conclusions code 1 updated.Conclusions code 1: code 4315 - the devices were discarded at the facility.Therefore no evaluation of the devices was able to be performed.Reportedly the reason for the explant of the descending aortic devices was not specified.Therefore cause was unable to be established.
Additional Manufacturer Narrative
Additional information - cause of death established: reportedly the patient developed complete av block post reintervention (procedure performed december 19, 2018) and was unable to be resuscitated.H.6.Conclusions code 2 additional code added h.6.Conclusions code 2: code 22 - according to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® thoracic endoprosthesis may include, but are not limited to, dissection of the aortic vessel and reoperation.

• 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: 8426937
• Report Number: 2017233-2019-00150
• Device Sequence Number: 1795717
• Product Code: MIH
• UDI-Device Identifier: 00733132617753
• UDI-Public: 00733132617753
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/11/2019

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: 09/30/2016
• Device Catalogue Number: TGU454520
• Device Lot Number: 11934561
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 03/16/2019
• Supplement Report FDA Received Date: 06/05/2019; 06/06/2019; 06/11/2019
• 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; Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 78