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

Catalog Number	TGU343420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/15/2019
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 endoleaks.Additionally, users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2019 a patient underwent treatment of a debakey type ii aortic dissection with 2 gore® ascending stent grafts 1 aortic component from the gore tag® thoracic branch enodprosthesis system, 1 side branch component from the gore tag® thoracic branch enodprosthesis system and 1 conformable gore® tag® thoracic endoprosthesis.The largest recorded aortic measurement recorded was 55mm, at the primary entry tear.On (b)(6) 2019 a type ii endoleak was discovered by ct.The maximum aortic measurement is not indicated in the report.On (b)(6) 2019 an attempt to reintervene on the type ii endoleak was made.However the procedure was discontinued after a snare wire, introduced through a non-gore snare catheter sheath caused a puncture in the right common iliac artery.This was repaired and a decision was made to reschedule the treatment for the type ii endoleak.Incidentally, a right brachial hematoma was found on the same day and treated by means of thrombectomy, but no gore devices were associated with this hematoma.No transfusion was required.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: 9434359
• Report Number: 2017233-2019-01220
• Device Sequence Number: 469444
• Product Code: MIH
• UDI-Device Identifier: 00733132618170
• UDI-Public: 00733132618170
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2019

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: 09/18/2020
• Device Catalogue Number: TGU343420
• Device Lot Number: 17301174A
• 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: 12/06/2019
• 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: 64 YR
• Patient Weight: 71