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

Catalog Number	TGU343415
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Hematoma (1884); Aortic Dissection (2491)
Date of Event	01/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Also was involved tgu343410/15036706, udi # (b)(4).According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to aortic expansion (e.G., aneurysm, false lumen, landing zone, lesion), endoleak, hematoma, reoperation and surgical conversion.The date of event will be used as (b)(6) 2017, the date of the additional endovascular procedure.
Event or Problem Description
On (b)(6) 2016, a patient underwent treatment of a type b uncomplicated aortic dissection with two conformable gore® tag® thoracic endoprostheses.The patient tolerated the initial procedure.On (b)(6) 2016, a cta revealed the maximum diameter of aortic aneurysm/lesion was 51mm.From (b)(6) 2017 to (b)(6) 2018 cta revealed that the maximum diameter of aortic aneurysm/lesion increased in size from 54mm to 74mm.On (b)(6) 2018, a cta revealed the aneurysm measured 36mm.On (b)(6) 2018, a cta revealed the aneurysm measured 37mm.Reportedly, on (b)(6) 2017, the patient underwent endovascular procedure and an additional endograft (unknown) was implanted.On (b)(6) 2017, the coil embolization of outflow vessel to thoracic aorta false lumen was performed.On (b)(6) 2017, a type i endoleak was identified.According to the information provided the event was related to aortic device or procedure.Reportedly, on (b)(6) 2018, the patient underwent conversion to open repair.Additionally, a hematoma was noticed and on (b)(6) 2018, the patient was returned to or for evacuation of hematoma.No further adverse events have been reported.
Event or Problem Description
On (b)(6), 2016, a patient underwent treatment of a type b uncomplicated aortic dissection with two conformable gore® tag® thoracic endoprostheses.The maximum aortic diameter size of the treated area is not available.The patient tolerated the initial procedure.On (b)(6), 2016, a cta revealed the maximum diameter of aortic aneurysm/lesion was 51mm.From (b)(6), 2017 to (b)(6), 2018 cta revealed that the maximum diameter of aortic aneurysm/lesion increased in size from 54mm to 74mm.On (b)(6), 2018, a cta revealed the aneurysm measured 36mm.On (b)(6), 2018, a cta revealed the aneurysm measured 37mm.Reportedly, on (b)(6), 2017, the patient underwent endovascular procedure and an additional endograft (unknown) was implanted.On (b)(6), 2017, a coil embolization of outflow vessels to the thoracic aorta false lumen was performed.On (b)(6), 2017, a distal type i endoleak was identified.According to the information provided the event was related to aortic device or procedure, however the device involved was not available.Reportedly, on (b)(6), 2018, the patient underwent conversion to open repair.It is not known whether gore devices were explanted.Additionally, a hematoma was noticed and on (b)(6), 2018, the patient was returned to or for evacuation of hematoma.No further adverse events have been reported.
Additional Manufacturer Narrative
B.5.Updated.H.6.Conclusion code 2: 22: according to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to endoleak, aneurysm enlargement, and hematoma.

• 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: 8839601
• Report Number: 2017233-2019-00581
• Device Sequence Number: 2196074
• Product Code: MIH
• UDI-Device Identifier: 00733132618156
• UDI-Public: 00733132618156
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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: 01/25/2019
• Device Catalogue Number: TGU343415
• Device Lot Number: 14797132
• 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: 07/29/2019
• Supplement Report FDA Received Date: 09/27/2019
• 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: 62 YR
• Patient Weight: 100