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

Catalog Number TGU262615J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Aortic Dissection (2491)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

Patient weight: asked but unavailable.Date of event: as the date of the follow up examination was reported as an unknown date in (b)(6) 2020, (b)(6) 2020 is being used as an estimated date of event.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.

Event Description

On (b)(6) 2018 the patient underwent endovascular treatment of a thoracic aortic aneurysm using two conformable gore® tag® thoracic endoprostheses (ctag).Ctag device tgu262615j was implanted distally and ctag device tgu343415j was implanted proximally.It was reported that a small ulcer-like projection (ulp) was observed at the distal end of the distal device.At the follow up examination on an unknown date in (b)(6) 2020 aortic dissection was noted at the distal edge of the distal ctag device.It was also reported that the ulp noted during the index procedure at the distal end of the distal ctag device had expanded postoperatively.On (b)(6) 2020 re-intervention was performed.An additional stent graft was implanted distally to cover the ulp.There were no further reported issues.The patient tolerated the procedure.

Manufacturer Narrative

Additional devices included on this report are as follows: catalog #tgu343415j, serial #(b)(6), udi #(b)(4), which is captured in manufacturer report #2017233-2020-01438.H.6.Results code 1 updated.H.6.Conclusions code 1 updated.H.6.Conclusions code 1: code 22 - according to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® thoracic endoprosthesis include, but are not limited to, aortic expansion (e.G., aneurysm, false lumen, landing zone, lesion), dissection, perforation, or rupture of the aortic vessel & surrounding vasculature, and reoperation.Furthermore, the ifu states that the gore® tag® thoracic endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta, including isolated lesions in patients who have appropriate anatomy, including = 20 mm non-aneurysmal aorta proximal and distal to the lesion.

• 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
• MDR Report Key: 10817801
• MDR Text Key: 215572584
• Report Number: 2017233-2020-01437
• 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
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

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: 10/10/2019
• Device Catalogue Number: TGU262615J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 11/16/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR