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

Model Number PLC271400

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2023

Event Type  malfunction  

Event Description

Opened a 16mm x 27mm gore contralateral leg stent to the sterile field.Scrub nurse attempted to flush stent with heparinized saline, but was unable.Doctor attempted to troubleshoot.They could not successfully feed an endowire through the front or back part of the stent, indicating some type of blockage/obstruction.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• 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: 19213365
• MDR Text Key: 341392245
• Report Number: 19213365
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618606
• UDI-Public: (01)00733132618606
• 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: 01/25/2024

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: PLC271400
• Device Catalogue Number: PLC271400
• 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: 01/25/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 83 KG