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

Catalog Number	TGU454510
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information has been requested regarding the device.Awaiting confirmation of device discardment.The review of the manufacturing paperwork verified that the lot met all pre-release specifications.
Event or Problem Description
The following information was reported to gore using an fda implanted and explanted devices form: it was reported that a conformable gore® tag® thoracic endoprosthesis (ctag) was used to treat an unknown etiology.On (b)(6) 2019 the ctag device (lot #16103109) was reportedly implanted and explanted.The fda implanted and explanted devices form lists "patient anatomy" as the reason for action.No further event information was provided.Further investigation is required.
Additional Manufacturer Narrative
Conclusions code 2 updated.Conclusions code 2: code 4315- the physician's office responded that no further information would be provided.Therefore, the cause for device implant and explant was not established.

• 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: 8538142
• Report Number: 2017233-2019-00270
• Device Sequence Number: 16233373
• Product Code: MIH
• UDI-Device Identifier: 00733132617746
• UDI-Public: 00733132617746
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: 02/28/2020
• Device Catalogue Number: TGU454510
• Device Lot Number: 16103109
• 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: 04/22/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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: Other
• Patient Age: 62 YR