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	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	09/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore through the pivotal study for the gore® tag® thoracic branch endoprosthesis (tbe device): on (b)(6) 2019, the patient underwent treatment of a residual descending thoracic aortic dissection, zone 2 with one conformable gore® tag® thoracic endoprosthesis and three investigational gore® tag® thoracic branch endoprostheses.On (b)(6) 2019, the patient was diagnosed with a poly-microbial bacteremia + s.Mitis, saprophytic neisseria infection.The infection was treated with drug therapy via a picc line.
Additional Manufacturer Narrative
Results code 1: 213: a review of the manufacturing and sterilization records for the device verified the lot met all pre-release specifications.Conclusion code 1: 22: according to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to infections.
Event or Problem Description
The following information was reported to gore through the pivotal study for the gore® tag® thoracic branch endoprosthesis (tbe device): on (b)(6) 2019, the patient underwent treatment of a residual descending thoracic aortic dissection, zone 2 with one conformable gore® tag® thoracic endoprosthesis and three investigational gore® tag® thoracic branch endoprostheses.On (b)(6) 2019, the patient was diagnosed with a poly-microbial bacteremia + s.Mitis, saprophytic neisseria infection.The infection was treated with drug therapy via a picc line.The infection was not thought to be device related.There was no obvious source and the patient was to follow-up with an infectious disease provider.At the thirty day follow-up appointment the patient was doing well.He still had his picc line in place to complete his six week drug therapy.

• 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: 9338791
• Report Number: 2017233-2019-01157
• Device Sequence Number: 14014036
• Product Code: MIH
• UDI-Device Identifier: 00733132618187
• UDI-Public: 00733132618187
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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: 05/14/2022
• Device Catalogue Number: TGU373715
• Device Lot Number: 20918723
• 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: 11/18/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 129