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	Aneurysm (1708)
Date of Event	06/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to endoleak and aneurysm enlargement.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2016 a patient was undergoing treatment of a descending thoracic aneurysm, zone 4, measuring 60.6mm with a conformable gore® tag® thoracic endoprosthesis.An undefined type i endoleak was reported.On (b)(6) 2016 the aneurysm measured 47mm by ct.On (b)(6) 2017 the aneurysm measured 59mm by ct.On (b)(6) 2017 the aneurysm measured 64mm by ct.On (b)(6) 2017 the aneurysm measured 60mm by ct.On (b)(6) 2018 a reintervention, whereby a total aortic arch repair with debranching to left common carotid and right common carotid, took place.
Additional Manufacturer Narrative
B.3.Updated.
Additional Manufacturer Narrative
B.5.Updated.
Event or Problem Description
The following information was reported to gore: on (b)(6), 2016 a patient was undergoing treatment of a descending thoracic aneurysm, zone 4, masuring 60.6mm with a conformable gore® tag® thoracic endoprosthesis.A proximal type i endoleak was reported.On (b)(6), 2016 the aneurysm measured 47mm by ct.On (b)(6), 2017 the aneusrysm measured 59mm by ct.On (b)(6), 2017 the aneurysm measured 64mm by ct.On (b)(6), 2017 the aneurysm measured 60mm by ct.On (b)(6), 2018 a reintervention, whereby a total aortic arch repair with debranching to left common carotid and right common carotid, took place.The endoleak was resolved.

• 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: 8809933
• Report Number: 2017233-2019-00541
• Device Sequence Number: 321109
• Product Code: MIH
• UDI-Device Identifier: 00733132617753
• UDI-Public: 00733132617753
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2019

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: 01/06/2019
• Device Catalogue Number: TGU454520
• Device Lot Number: 14739272
• 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
• Initial Report FDA Received Date: 07/20/2019
• Supplement Report FDA Received Date: 08/26/2019; 08/26/2019
• 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: 78 YR
• Patient Weight: 81