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

Catalog Number RLT281216J

Device Problem Device Handling Problem (3265)

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

The gore® excluder® aaa endoprostheses instructions for use states, ¿it is recommended to view and confirm the distal position of the iliac end of the device relative to the internal iliac artery to ensure accurate and desired deployment position of the distal aspect of the device.¿ in addition, the ifu states that potential adverse events that may occur and/or require intervention include, but are not limited to, improper component placement and occlusion of native vessel.

Event Description

On (b)(6) 2021, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.During the procedure, it was reported the ipsilateral limb was deployed without contrast.At the final angiography, it was confirmed the right internal iliac artery was covered by the device.The patient was decided to be monitored and the procedure was completed.The physician reported that he should have identified the right internal iliac artery using by angiography before the device was fully deployed.

• Brand Name: GORE EXCLUDER AAA 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
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12488431
• MDR Text Key: 274462362
• Report Number: 3007284313-2021-01588
• 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: 09/17/2021

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: 06/15/2023
• Device Catalogue Number: RLT281216J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/17/2021
• Date Device Manufactured: 06/15/2020
• 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): Other
• Patient Age: 73 YR