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 Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the gore® tag® thoracic branch endoprostheses instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to endoleaks.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018, the patient underwent endovascular treatment of a descending thoracic aortic dissection, distal to the left common carotid artery ostium and proximal to the left subclavian artery, with two gore® tag® thoracic branch endoprostheses (tac123720c/17586918 and tsb121506c/16287330) and two conformable gore® tag® thoracic endoprostheses (tgu343410/17951220-most adjacent to aortic component and tgu373715/17977144-distal extension).According to the report, the total treatment length was 14 cm with the left subclavian artery the intended branch vessel to be treated.The patient tolerated the procedure.It was reported that post implant images revealed a type ii endoleak, with no aneurysm growth and no reintervention.(captured event # (b)(4)).The database has been updated.The date the type ii endoleak was discovered by images was (b)(6) 2018.On (b)(6) 2018, a ct scan revealed an additional indeterminant endoleak.The type ii endoleak was also still present.On (b)(6) 2019 ct images revealed the following: coils have been implanted in the false lumen at the distal end of ctag 1, ctag 2, and extends distal to the right renal artery.There is ct spray artifact that limits aortic visualization,observations.The type ii endoleak was reportedly originating from intercostal arteries.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018, the patient underwent endovascular treatment of a descending thoracic aortic dissection, distal to the left common carotid artery ostium and proximal to the left subclavian artery, with two gore® tag® thoracic branch endoprostheses (tac123720c/17586918 and tsb121506c/16287330) and two conformable gore® tag® thoracic endoprostheses (tgu343410/17951220-most adjacent to aortic component and tgu373715/17977144-distal extension).According to the report, the total treatment length was 14 cm with the left subclavian artery the intended branch vessel to be treated.The patient tolerated the procedure.During this procedure, embolization coils were implanted at the distal ends of the ctag devices to occlude the false lumen.The coils extend distal to the right renal artery.The maximum aortic diameter within the treated segment was 61.6mm.It was reported that post implant images revealed a type ii endoleak, with no aneurysm growth and no reintervention.The database has been updated.The date the type ii endoleak was discovered by images was (b)(6) 2018.On (b)(6) 2018 a ct scan showed the maximum aortic diameter within the treated segment was 61.8mm on (b)(6) 2018, a ct scan revealed an additional indeterminate endoleak.The type ii endoleak was also still present.The maximum aortic diameter within the treated segment was 56mm.On (b)(6) 2019 ct images revealed the following: coils have been implanted in the false lumen at the distal end of ctag 1, ctag 2, and extends distal to the right renal artery.There is ct spray artifact that limits aortic visualization observations.The type ii endoleak was reportedly originating from intercostal arteries.The maximum aortic diameter within the treated segment was 53.5mm.
Additional Manufacturer Narrative
B.5.Updated.H.1.Medwatch # 2017233-2019-00503 was sent in error.Additional received information determined that this event is not reportable to the fda and therefore the medwatch is being retracted.H.6.Patient code 1 updated.H.6.Device code 1 updated.H.6.Conclusion code 1 updated.

• 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: 8762749
• Report Number: 2017233-2019-00503
• Device Sequence Number: 11393848
• Product Code: MIH
• UDI-Device Identifier: 00733132618187
• UDI-Public: 00733132618187
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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: 03/18/2021
• Device Catalogue Number: TGU373715
• Device Lot Number: 17977144
• 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: 07/04/2019
• Supplement Report FDA Received Date: 08/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H.10./11.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 72