MAUDE Adverse Event Report: W. L. GORE ASSOCIATES, INC. GORE EXCLUDER CONF AAA ENDO - TRUNK-IPSILATERAL; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number CXT261412

Patient Problem Foreign Body In Patient (2687)

Event Date 11/08/2023

Event Type  malfunction  

Event Description

The olive tip of the aortic endoprosthesis delivery device was retained within the abdominal aortic aneurysm sac.Upon removal of the main body aortic endoprosthesis delivery device, the olive tip of the endoprosthesis delivery system did break off into the aortic aneurysm sac.Multiple subtraction angiograms demonstrated that the olive tip was remote from the sheath tips and inaccessible with snare.

• Brand Name: GORE EXCLUDER CONF AAA ENDO - TRUNK-IPSILATERAL
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE ASSOCIATES, INC.; 1505 north fourth st; flagstaff AZ 86004
• MDR Report Key: 18766811
• MDR Text Key: 336104987
• Report Number: 18766811
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CXT261412
• Device Catalogue Number: CXT261412
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male