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

Device Problems Material Invagination (1336); Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

The lot numbers of the gore devices were not provided.Therefore, a review of the manufacturing records could not be performed and the udi numbers are not available.According to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to device migration.

Event Description

On (b)(6) 2019 the patient had a follow-up cta scan for a conformable gore® tag® thoracic endoprosthesis implanted just under a month ago for treatment of a type a aortic dissection.The cta scan indicated that there was bird-beaking and potential migration of the conformable gore® tag® thoracic endoprosthesis that was placed in the descending thoracic aorta.It was reported that the device may have been placed into zone 2, with a bypass of the left common carotid to left subclavian.It was reported that the device was deployed in a curve in an inverse orientation (deployed from above through an open sternotomy/ascending aorta).It is reported that the physician only suspects migration, and the distance is unknown.The patient will continue to be monitored and no further treatment is taking place at this time.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: sara collum ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8768034
• MDR Text Key: 150283670
• Report Number: 2017233-2019-00504
• 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: 06/12/2019

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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