MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGMR313110
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The fsa reported: on (b)(6) 2021, this patient underwent open aortic arch repair and treatment for a descending thoracic aortic dissection.A frozen elephant procedure was performed first for the descending thoracic aorta replacement.A gore® tag® conformable thoracic stent graft with active control system was advanced distally for antegrade deployment and fully deployed to its full diameter.All four handles were pulled out and deployed without issue however the device stayed connected to the delivery catheter inside the sleeve.The physician cut the delivery system out and the procedure was concluded.The patient tolerated the procedure with good results.
Additional Manufacturer Narrative
H6: code 213 ¿ a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Testing indicated no deficiencies could be identified in performance or manufacturing.
Additional Manufacturer Narrative
G4 date was added as this was previously omitted in supplemental 1.

• Brand Name: GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11402082
• Report Number: 2017233-2021-01728
• Device Sequence Number: 16924366
• Product Code: MIH
• UDI-Device Identifier: 00733132646777
• UDI-Public: 00733132646777
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: PO40043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2023
• Device Model Number: TGMR313110
• Device Catalogue Number: TGMR313110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 02/12/2021; 08/25/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 06/17/2021; 08/25/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 62 YR