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 TGM343420

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Aortic Dissection (2491)

Event Date 03/05/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 this patient underwent endovascular treatment of a type b aortic dissection from the subclavian artery to the left vertebral artery using conformable gore® tag® thoracic endoprosthesis with active control (ctag/ac).The device was implanted the level of the carotid artery, although the gore field sales associate (fsa) advised against this due to lack of appropriate healthy seal zone.The fsa became aware on september 17, 2020 that on or about (b)(6) 2020 a carotid artery to left common carotid artery bypass was performed in order to maintain proximal seal of the ctag/ac device.On (b)(6) 2020, images were read that showed the proximal end of the most proximal ctag/ac device had moved through the septum of the dissection into the false lumen.The physician feels this may have occurred due to the original positioning of the ctag/ac device, and that due to the lack of appropriate seal zone the device "moved up" and through the dissected tissue into the false lumen.No reintervention is scheduled at this time and no further information is available.

• 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: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10678590
• MDR Text Key: 211446337
• Report Number: 2017233-2020-01350
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132646975
• UDI-Public: 00733132646975
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2020

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
• Device Expiration Date: 06/19/2022
• Device Model Number: TGM343420
• Device Catalogue Number: TGM343420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/14/2020
• Date Device Manufactured: 06/20/2019
• 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): Other
• Patient Age: 30 YR
• Patient Weight: 111