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

Model Number	TGT3115
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Codes	Aneurysm (1708); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.It should be noted the gore® tag® thoracic endoprosthesis instructions for use states ¿complications associated with the use of the gore® tag® thoracic endoprosthesis may include, but are not limited to, endoleak and aneurysm expansion.¿.
Event or Problem Description
On (b)(6) 2013, a patient underwent surgical repair of a thoracic aortic aneurysm with arch replacement and an elephant trunk procedure, and then endovascular treatment from the elephant trunk to the descending aorta using two gore® tag® thoracic endoprostheses.A 31mm gore® tag® device was implanted proximally, and a 34mm gore® tag® device was implanted distally.On unknown date, a follow-up computed tomography scan reportedly revealed aneurysm enlargement (amount not reported), and a suspected type ia or type ii endoleak at the proximal send of the aneurysm.On (b)(6) 2021, a reintervention was performed.An angiograph prior to the procedure reportedly showed no significant endoleak.However, the physician suspected a slight proximal type i endoleak from between the elephant trunk and the proximal gore® tag® device due to a gap or insufficient overlap length.An additional 31mm gore® tag® device was implanted to extend to the proximal side.A final procedural angiograph revealed no endoleak.The patient tolerated the procedure.

• Brand Name: GORE TAG THORACIC ENDOPROSTHESIS
• 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: 12334045
• Report Number: 2017233-2021-02277
• Device Sequence Number: 2806441
• Product Code: MIH
• UDI-Device Identifier: 00733132613625
• UDI-Public: 00733132613625
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2021

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: 03/31/2016
• Device Model Number: TGT3115
• Device Catalogue Number: TGT3115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/17/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR