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

Catalog Number TGU404015J

Device Problems Use of Device Problem (1670); Unintended Movement (3026)

Patient Problems Aneurysm (1708); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device remains implanted and is not available for analysis.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), determine accurate size of anatomy and proper device size.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.The gore® tag® thoracic endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta, including: = 20 mm non-aneurysmal aorta proximal and distal to the lesion.Use of the gore® tag® thoracic endoprosthesis outside of the recommended anatomical sizing guidelines may result in potentially serious device-related events (e.G., device infolding, excessive device compression, endoleak, wire fracture, migration).Complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to: endoleak, aortic expansion (e.G., aneurysm, false lumen, landing zone, lesion), aortic rupture, endoprosthesis migration and reoperation.

Event Description

On (b)(6) 2017, the patient underwent endovascular treatment of a thoracic aortic aneurysm using a conformable gore® tag® thoracic endoprosthesis.Reportedly, on (b)(6) 2021, the ct imaging revealed a distal type i endoleak and an aneurysm enlargement.Additionally, a proximal device migration was observed.It was reported that the proximal migration of the distal side of the device was attributed to the type i endoleak and the aneurysm enlargement.On (b)(6) 2021, an emergent reintervention was performed and additional two stent grafts were placed to treat the distal type i endoleak, the aneurysm enlargement and the device migration.Also, an aneurysm rupture was observed.The patient tolerated the procedure.It was reported that the length of the distal landing side at the initial procedure might not enough.According to the physician, the short distal landing zone (unknown length) might have caused the endoleak and subsequently other issues.

• Brand Name: CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS
• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11319112
• MDR Text Key: 234927525
• Report Number: 2017233-2021-01665
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2019
• Device Catalogue Number: TGU404015J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2021
• Date Device Manufactured: 12/09/2016
• 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; Required Intervention
• Patient Age: 87 YR