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

Catalog Number PLC231200J

Device Problem Unintended Movement (3026)

Patient Problems Ruptured Aneurysm (4436); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/12/2022

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.The device remains implanted and is not available for analysis.The additional information was requested but is not available.The physician stated that the patient's anatomy was tortuous.But there was no comment from the physician about the cause of the migration.According to the gore® excluder® aaa endoprostheses instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to component migration, endoleak and aneurysm rupture.Also, the ifu states: additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.Ilio-femoral access vessel size and morphology (minimal thrombus, calcium and / or tortuosity) should be compatible with vascular procedure.

Event Description

On an unknown date, the patient underwent an endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On (b)(6) 2022, the patient was taken to the hospital because of an aneurysm rupture which was caused by a distal type i endoleak from the right leg due to the proximal device migration (distance is unknown).The right internal iliac artery was embolized and two contralateral leg components (plc121400j and plc121200j) were implanted distally on the right limb.The endoleak was resolved.The patient tolerated the procedure.The physician stated that the patient's anatomy was tortuous.But there was no comment from the physician about the cause of the migration.

• 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 WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15080466
• MDR Text Key: 296371563
• Report Number: 2017233-2022-03145
• 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: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PLC231200J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• 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; Hospitalization; Required Intervention