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

Catalog Number RLT231216J

Device Problem Compatibility Problem (2960)

Patient Problem Aneurysm (1708)

Event Date 11/11/2017

Event Type  Injury  

Manufacturer Narrative

The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

Event Description

On (b)(6) 2017, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.On an unknown date, estimated to be on or about (b)(6) 2017, a distal type i endoleak originating from the right ipsilateral limb was observed.On (b)(6) 2019, the patient underwent re-intervention for treatment of the distal type i endoleak and coil-embolization of the right internal iliac artery (riia) was performed with placement of an additional stent graft was implanted within the right external iliac artery (reia) with to extend coverage, intentionally covering (riia).The patient tolerated the procedure and the endoleak was resolved.The physician stated that the sealing length at the right common iliac artery was short, and the vascular condition was not good.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: laura crawford ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9186192
• MDR Text Key: 173232715
• Report Number: 3007284313-2019-00308
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• 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: 10/02/2019

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
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: RLT231216J
• Device Lot Number: 15742938
• 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: 10/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2016
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 78 YR