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

Model Number	TGU262110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2015, this patient suffered a traumatic thoracic aortic transection following a skydiving accident.The patient underwent endovascular treatment using a gore® conformable tag® thoracic endoprosthesis.On (b)(6) 2020, the patient contacted a gore representative and indicated that he checked himself into a hospital due to covid-19 like symptoms.Computed tomography (ct) was performed, which revealed possible infection in the area around the gore® ctag® device.The patient was not diagnosed with any illness prior to the ct scan.The patient was started on a regimen of antibiotics.On (b)(6) 2020, a biopsy/tissue with gram stain was performed.The results indicated a rare number streptococcus anginosus group and rare to small number gram positive cocci in pairs.No polymorphonuclear cells were seen.Therefore, on (b)(6) 2020, the patient underwent an explant of the ctag® device, and open replacement of the descending aorta with aortic homograft, omental flap, and intercostal muscle flap.The patient will be maintained on ceftriaxone for six weeks post-surgery.
Additional Manufacturer Narrative
Additional manufacturer narrative/corrected data - patient underwent explant of the thoracic endograft and open replacement of the descending thoracic aorta with aortic homograft, omental flap, and intercostal muscle flap on (b)(6) 2020.He will be maintained on ceftriaxone for 6 weeks.

• 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: 10029066
• Report Number: 2017233-2020-00332
• Device Sequence Number: 19787543
• Product Code: MIH
• UDI-Device Identifier: 00733132617791
• UDI-Public: 00733132617791
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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: 03/17/2018
• Device Model Number: TGU262110
• Device Catalogue Number: TGU262110
• Device Lot Number: 13945922
• 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: 05/06/2020
• Supplement Report FDA Received Date: 06/10/2020
• 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: Other; Required Intervention
• Patient Age: 41 YR