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	TGM343410
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications include lisinopril, metformin, and rosuvastatin (crestor).(b)(4) ¿ a review of the manufacturing records for the device verified that the lot met all pre-release specifications.(b)(4): the device remains implanted and, therefore, was not available for direct analysis by gore.It should be noted the gore® tag® conformable thoracic stent graft instructions for use states ¿complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to improper stent graft placement and branch vessel occlusion or obstruction.".
Event or Problem Description
On (b)(6), 2011, the patient was implanted with a gore® tag® conformable thoracic stent graft to treat a penetrating aortic ulcer.During the procedure, the physician had reportedly planned to land the proximal end of the device at the mid-ostium of the left subclavian artery (lsa) due to a short landing zone.Upon deployment, it was noted the device had unintentionally covered the lsa.The cause of the unintended placement is unknown.A stent was implanted in the lsa to preserve blood flow, and the case went forward to completion without any further reported complications.The patient tolerated the procedure.

• 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: 11473133
• Report Number: 2017233-2021-01758
• Device Sequence Number: 3598038
• Product Code: MIH
• UDI-Device Identifier: 00733132646951
• UDI-Public: 00733132646951
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

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: 08/14/2022
• Device Model Number: TGM343410
• Device Catalogue Number: TGM343410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 127