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	TGM454515
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Images were returned for evaluation.The evaluation stated: one time-point available for evaluation: post-implantation cta dated (b)(6) 2022.Comparison series axial images appear to show a possible lack of proximal device apposition on the inner curve.Comparison axial images does not show an increase in pooling contrast on the delayed contrast series, thereby, ruling out a type ii endoleak.There appears to be bright contrast outside the implanted device communicating with contrast inside the device ~24mm, by outer curve length, distal to the proximal circumferential end of the device.Cannot confirm communication between the small amount of contrast outside the proximal device and the contrast pooling distally.(~24mm distal).Probable type iii endoleak.
Event or Problem Description
On (b)(6) 2021, the patient was treated for kommerell divirticulum/ aberrant sublclavian.The physician implanted a gore® tag® conformable thoracic stent graft with active control system.The patient tolerated the procedure.On (b)(6) 2022, the gore fsa received a scan from the physician that appears to be a possible type iii endoleak.Images were received for evaluation.As of this time, the physician has not taken any action to address the endoleak.
Additional Manufacturer Narrative
Additional information was received that a reintervention was performed to repair the reported endoleak.No endoleak was seen on angiogram images.Event type was changed from product malfunction to serious injury.

• 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
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14194120
• Report Number: 2017233-2022-02880
• Device Sequence Number: 17237779
• Product Code: MIH
• UDI-Device Identifier: 00733132646999
• UDI-Public: 00733132646999
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• 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
• Report Date (Section B): 07/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2024
• Device Model Number: TGM454515
• Device Catalogue Number: TGM454515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male