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	11/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: (b)(4), lot # 13951116, (b)(4).It is not known which device was associated with the dissection therefore both were investigated.A review of the manufacturing records for the devices verified the lots met all pre-release specifications.
Event or Problem Description
The following information was reported to gore through the (b)(6) registry for endovascular aortic treatment (great 10-11): on (b)(6) 2015, the patient underwent treatment of a 60 mm descending thoracic aortic (dta) aneurysm 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 dta measured 57 mm.On (b)(6) 2016, follow up imaging identified a persistent endoleak (type of endoleak not reported).It is unknown if aneurysm enlargement occurred.On (b)(6) 2016, coil embolization was performed to treat the endoleak.(captured event (b)(4).On (b)(6) 2017 the patient underwent cerebral debranching of the ascending aorta due to a type b dissection.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.
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.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.

• 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: 8589229
• Report Number: 2017233-2019-00325
• Device Sequence Number: 1836604
• 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): 05/15/2019

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: 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: 05/07/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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
• Patient Age: 70 YR
• Patient Weight: 123