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

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: as the actual implant date was unknown, it was estimated to be on or about (b)(6) 2020.A review of the manufacturing records for the device was unable to be conducted as no lot number was available; as such, no udi was generated.According to the instructions for use (ifu) for the gore® tag® thoracic endoprosthesis; adverse events which may require intervention and / or conversion to open repair include, but are not limited to: branch vessel occlusion.

Event Description

On an unknown date estimated to be on or about (b)(6) 2020, this patient underwent endovascular treatment and was implanted with a gore® tag® conformable thoracic stent graft.Post deployment it was reported that there was unintentional coverage by the device of supra aortic branch vessels.The patient tolerated the procedure.No additional patient details or event details were provided by the physician; and no gore associate was reported to have supported the case.

• Brand Name: GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Type of Device: 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10317877
• MDR Text Key: 200242199
• Report Number: 2017233-2020-01050
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 07/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other