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

Catalog Number	TGU373715
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: tgu373710/14559103.Images were sent to gore imaging services for evaluation.Per the evaluation one time-point available for evaluation, post-implantation cta dated (b)(6) 2019.There appears to be two ctag® devices implanted.Comparison axial image series for arterial contrast and delayed contrast appear to show, contrast can be visualized pooling in the sac on the delayed image set at many levels.Possible intercostal communication.Increased pooling contrast on the delayed images can be suggestive of a type ii endoleak.There appears to be ~4.7cm of device overlap.There appears to be less than ~12mm of device seal distal to the aneurysmal sac to the celiac.Cannot confirm, with available imaging, if the endoleak is a type ii from intercostal arteries or a distal type i.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis that may occur and/or require intervention include, but are not limited to endoleak.
Event or Problem Description
On (b)(6) 2017, the patient was implanted with two conformable gore® tag® thoracic endoprostheses to treat a descending thoracic aortic aneurysm.It was reported that computed tomography (cta) images dated (b)(6) 2019, revealed an unknown endoleak.Possibly a type ii endoleak or a distal type i endoleak.It is unknown if there is aneurysm sac enlargement.No reintervention has been planned, the physician is taking a wait and watch approach.The event is ongoing.

• 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: 8654304
• Report Number: 2017233-2019-00381
• Device Sequence Number: 2662555
• Product Code: MIH
• UDI-Device Identifier: 00733132618187
• UDI-Public: 00733132618187
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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: 06/22/2018
• Device Catalogue Number: TGU373715
• Device Lot Number: 14118623
• 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: 05/30/2019
• 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: Other
• Patient Age: 84 YR