MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number RMT281416

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Code Available (3191)

Event Date 03/19/2015

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to endoleak and aneurysm enlargement.

Event Description

The following was reported to gore: on (b)(6) 2013, the patient presented with an abdominal aortic aneurysm (diameter 55mm) that was treated with the implantation of gore® excluder® aaa endoprostheses.Follow-up imaging performed on (b)(6) 2015, showed aneurysm growth (diameter 58mm).On (b)(6) 2015, a proximal type i endoleak was identified and successfully treated with the implantation of an aortic extender endoprosthesis on (b)(6) 2015.The patient tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: joerg kersten ; 9285263030
• MDR Report Key: 7657685
• MDR Text Key: 112994304
• Report Number: 2017233-2018-00363
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132610723
• UDI-Public: 00733132610723
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2018

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: 10/31/2015
• Device Catalogue Number: RMT281416
• Device Lot Number: 10870320
• 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: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2012
• 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): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 90