MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number CEB231010A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Thrombosis (2100)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.According to the instructions for use for the gore® excluder® aaa endoprosthesis, additional considerations for patient selection include but are not limited to: minimal thrombus, calcium and / or tortuosity.

Event Description

On (b)(6) 2018, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis featuring c3® delivery system.On (b)(6) 2018, a thrombosis of the right external iliac artery (reia) was observed.A thrombectomy was performed and a bare metal stent was implanted to treat the reia.The procedure was concluded.The patient tolerated the procedure.It was reported that thrombosis of reia was due to a severe twist of the patient's anatomy.No further information was obtained.

Manufacturer Narrative

Event: added/corrected information.

Event Description

On (b)(6) 2018, the patient underwent endovascular treatment for an abdominal aortic aneurysm and bilateral common iliac artery aneurysms and was implanted with gore® excluder® aaa endoprosthesis featuring c3® delivery system and gore® excluder® iliac branch endoprostheses.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7431868
• MDR Text Key: 105514101
• Report Number: 3013164176-2018-00029
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2020
• Device Catalogue Number: CEB231010A
• Device Lot Number: 16486475
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 68 YR