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

Model Number	TGU313115
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: additional device: tgu373715, lot #: 13313131, udi: (b)(4).As it is not known which device or if both contributed to the distal migration, both are being investigated.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2016 a patient underwent treatment of a descending thoracic aneurysm with two conformable gore® tag® thoracic endoprostheses.On (b)(6) 2019 a reintervention took place to address distal migration of approximately 5mm.An additional conformable gore® tag® thoracic endoprosthesis was implanted proximally.The reason for the distal migration was asked, but is unknown.The patient tolerated the procedure.
Additional Manufacturer Narrative
H.6.Results code 1: 213: a review of the manufacturing records for the devices verified the lots met all pre-release specifications.H.6.Conclusion code 1: 22: according to the 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: endoprosthesis migrations.
Event or Problem Description
The following information was reported to gore: on (b)(6), 2016 a patient underwent treatment of a descending thoracic aneurysm with two conformable gore® tag® thoracic endoprostheses.On (b)(6) 2020 a reintervention took place to address distal migration of approximately 5mm.An additional conformable gore® tag® thoracic endoprosthesis was implanted proximally.The reason for the distal migration was asked, but is unknown.The patient tolerated the procedure.

• 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: 9547631
• Report Number: 2017233-2020-00009
• Device Sequence Number: 19439681
• Product Code: MIH
• UDI-Device Identifier: 00733132617814
• UDI-Public: 00733132617814
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2020

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: 05/02/2019
• Device Model Number: TGU313115
• Device Catalogue Number: TGU313115
• Device Lot Number: 15085617
• 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; Not provided
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 01/27/2020; 04/14/2020
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 71 YR