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

Device Problem Collapse (1099)

Patient Problem No Code Available (3191)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

Lot/serial numbers were not provided, therefore, a review of the manufacturing records could not be conducted.

Event Description

The following article was reviewed: ¿endovascular repair of blunt thoracic aortic trauma: is postimplant hypertension an incidental finding?¿ (konstantinos tigkiropoulos, et.Al, vann vasc surg, 2018, 50: 160-166, published online on march 7, 2018).The article analyzed the outcome of 23 patients that presented with blunt thoracic aortic trauma (btai) that underwent thoracic endovascular aortic repair (tevar) between january 2005 and january 2016.Patient 9 that was treated with two conformable gore® tag® thoracic endoprostheses showed signs of proximal collapse of the endograft on the second postoperative day.He was urgently transferred to the operating theater, and a proximal endograft extension was performed along with appropriate balloon dilatation and an innominate to the left carotid bypass.The patient tolerated the procedure.

Event Description

The following article was reviewed: ¿endovascular repair of blunt thoracic aortic trauma: is postimplant hypertension an incidental finding?¿ (konstantinos tigkiropoulos, et.Al, vann vasc surg, 2018, 50: 160-166, published online on (b)(6) 2018).The article analyzed the outcome of 23 patients that presented with blunt thoracic aortic trauma (btai) that underwent thoracic endovascular aortic repair (tevar) between january 2005 and january 2016.Patient 9 that was treated with two conformable gore® tag® thoracic endoprostheses showed signs of proximal collapse of the endograft on the second postoperative day.He was urgently transferred to the operating theater, and a proximal endograft extension was performed along with appropriate balloon dilatation and an innominate to the left carotid bypass.The physician stated that the aortic arch of the patient had an acute angle that might have contributed to the collapse of the device.The patient tolerated the procedure.

• 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
• MDR Report Key: 8472563
• MDR Text Key: 140590386
• Report Number: 2017233-2019-00194
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR