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

Catalog Number PLA280300

Device Problem Inaccurate Delivery (2339)

Patient Problem Occlusion (1984)

Event Date 02/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the devices verified the lots met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to improper component placement and occlusion.

Event Description

The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses featuring c3® delivery system.A trunk-ipsilateral leg component was deployed, then repositioned to preserve an accessory renal artery on the left.This device was deployed too low, inadvertently, compromising proximal seal, and was attempted to be repositioned, but could not be repositioned.The remainder of the device was deployed fully and the gore® excluder® aaa endoprosthesis contralateral leg component was also deployed.To address the low deployment of the gore® excluder® aaa endoprosthesis trunk-ipsilateral leg component, a gore® excluder® aaa endoprosthesis aortic extender was deployed.However, it was reportedly partially impinging upon the ostium of the right renal artery.An omnilink stent was deployed in the right renal artery.The patient tolerated the procedure.On (b)(6) 2018 the patient was doing well.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7278951
• MDR Text Key: 100404715
• Report Number: 2953161-2018-00020
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: PLA280300
• Device Lot Number: 14629497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2016
• 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: 79 YR