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	Vascular Dissection (3160)
Date of Event	12/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device: tgu373720, lot # 13951116, udi: (b)(4).It is not known which device was associated with the dissection therefore both are being investigated.
Event or Problem Description
On (b)(6) 2015, the patient underwent treatment of a 60 mm descending thoracic aortic aneurysm of chronic type b dissection etiology whereby two conformable gore® tag® thoracic endoprostheses were implanted in zone 3 of the proximal descending thoracic aorta.The patient tolerated the procedure.On (b)(6) 2015, follow up imaging showed the aorta measured 57 mm.On (b)(6) 2016, follow up imaging identified a ¿persistent endoleak,¿ later reported to be a distal type i endoleak.However, it was reported the ¿endoleak¿ was indicated to be a result of the pre-existing dissection and was reportedly caused by persistent flow into the false lumen.It was further reported the persistent false lumen perfusion originated below the treated segment of the aorta in an untreated area.The ¿endoleak¿ was reportedly not related to the gore devices, and there were no issues or allegations of deficiency related to the gore devices.It was reported no aneurysm or false lumen enlargement was identified.On (b)(6) 2016, coil embolization was performed to treat the endoleak.It was reported the coil embolization did not entirely resolve the persistent false lumen perfusion.The patient will reportedly continue to be monitored.The patient tolerated the procedure.Upon further investigation, it was determined the previously reported ¿persistent endoleak¿ was persistent false lumen perfusion distal to the area in which the ctag devices were implanted, in an untreated area.The coil embolization was reportedly performed to treat the persistent false lumen perfusion that was identified in an untreated area.It was further reported the persistent false lumen perfusion was not a result of the gore devices, and there were no reported issues or allegations of deficiency regarding the gore devices.There is nothing to reasonably suggest that the devices caused, or may have caused or contributed to a serious injury to this patient.(captured event # (b)(4)) on (b)(6) 2017 the patient underwent cerebral debranching of the ascending aorta due to a type b dissection.(captured event # (b)(4)) on (b)(6) 2017 a type a aortic dissection was reported.It is not known whether this dissection is a new one, or a continuation of the type b dissection.The dissection was treated by means of open repair and replacement of the ascending aorta through a re-do sternotomy.
Additional Manufacturer Narrative
H.6.Results code 1: 213: a review of the manufacturing records indicated the lots met pre-release specifications.H.6.Conclusion code 1: 22: according to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to surgical conversions.

• 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: 8761493
• Report Number: 2017233-2019-00499
• Device Sequence Number: 16803682
• Product Code: MIH
• UDI-Device Identifier: 00733132618187
• UDI-Public: 00733132618187
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 03/31/2018
• Device Catalogue Number: TGU373715
• Device Lot Number: 13785188
• 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
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/28/2019
• 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: 70 YR
• Patient Weight: 123