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	04/09/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: tgu373720/18696187.Udi: (b)(4).Concomitant medical products: patient medications: levophed, propofol, and fentanyl.(b)(6).
Event or Problem Description
On (b)(6) 2019, the patient was implanted with two conformable gore® tag® thoracic endoprostheses to treat a descending thoracic dissection.It was reported the patient presented to the emergency room and that computed tomography (ct) images dated (b)(6) 2019, revealed a type b dissection in the thoracic aorta as well as an aorta esophageal fistula.The ct also revealed the stent struts had penetrated through into the esophagus and that area is infected.The physician chose to implant an additional conformable gore® tag® thoracic endoprosthesis until the patient becomes stable for a possible explant procedure.It is unknown if there was an existing infection or an existing fistula, patient was implanted at a different facility.The patient tolerated the reintervention.
Event or Problem Description
Reportedly, the esophagus was diverted during the reintervention on (b)(6) 2019.While waiting to get the grafts explanted, the patient expired (exact date is not known).Cause of death is due to the esophagus complications and infection.(b)(6) 2019 will be used as date of death, since actual date is unknown, but the patient expired after 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: 8599928
• Report Number: 2017233-2019-00338
• Device Sequence Number: 2281122
• Product Code: MIH
• UDI-Device Identifier: 00733132618187
• UDI-Public: 00733132618187
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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: 08/28/2021
• Device Catalogue Number: TGU373715
• Device Lot Number: 18652802
• 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: 05/10/2019
• Supplement Report FDA Received Date: 08/05/2019
• 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: Death; Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 60