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

Catalog Number	TGU404015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic Dissection (2491)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications: plavix, metformin, and lisinopril.Ct images dated (b)(6) 2019, were sent to gore imaging services for evaluation.Per the evaluation there appears to be a lack of wall apposition at the distal end of the implanted device.Diameters with in the distal 2 cm of the implanted device range from 29 mm¿35 mm on average diameter.Length of the implanted device appears to measure ~ 15 cm along the outer curve.Unable to identify aneurysmal growth with only one time-point.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.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2018, the patient was implanted with conformable gore® tag® thoracic endoprostheses to treat a type b aortic dissection.It was reported that computed tomography images dated (b)(6) 2019, revealed a distal type i endoleak with device malposition on the distal end.It is unknown if there is aneurysm sac enlargement.On (b)(6) 2019, the physician reintervened and implanted a conformable gore® tag® thoracic endoprostheses and extended distally.The endoleak was resolved and the patient tolerated the reintervention.

• 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: 8844304
• Report Number: 2017233-2019-00585
• Device Sequence Number: 2515613
• Product Code: MIH
• UDI-Device Identifier: 00733132618163
• UDI-Public: 00733132618163
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2019

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: 08/16/2018
• Device Catalogue Number: TGU404015
• Device Lot Number: 14326040
• 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: 07/30/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 76