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

Model Number	TGU212110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2020, the patient was implanted with a conformable gore® tag® thoracic endoprosthesis (ctag) to treat an aortic transection.It was reported that the deployment of the ctag was completed successfully and there was no harm done to the patient.Upon removal of the catheter, the olive tip was caught in the valve of the cook 18f introducer sheath.The surgeon used force to attempt to pull the catheter from the introducer sheath and the olive tip became detached from the catheter and remained in the sheath.The procedure was completed with the ctag catheter still on the wire and the tip still stuck in the sheath.After a completion angiogram was performed, the physician removed the cook 18f sheath with the ctag cathether and amplatz super stiff guidewire all as one unit.The physician then successfully closed the access site.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition the device was returned to gore for evaluation.The device evaluation showed there is no leading olive attached to the leading end of the catheter.The delivery catheter near the expected location of the olive demonstrates characteristics of a tensile failure, which is consistent with the event description that the leading olive detached.The root cause for the leading olive break is due to resistive force, but of unknown sources that could potentially be caused by a feature within the introducer sheath.Addition h6: code 22-the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu) states the gore® tag® thoracic endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.Furthermore, do not continue advancement or retraction of the guidewire, sheath, or delivery catheter if resistance is felt.
Additional Manufacturer Narrative
Correction b3.Correction b4.

• 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: 9793203
• Report Number: 2017233-2020-00149
• Device Sequence Number: 2185211
• Product Code: MIH
• UDI-Device Identifier: 00733132617777
• UDI-Public: 00733132617777
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2020
• Device Model Number: TGU212110
• Device Catalogue Number: TGU212110
• Device Lot Number: 17389371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• 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: 03/05/2020
• Supplement Report FDA Received Date: 04/20/2020; 05/29/2020
• 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
• Patient Age: 44 YR