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

Catalog Number PXC141400

Device Problems Sticking (1597); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2015

Event Type  malfunction  

Manufacturer Narrative

Results code 1: a review of the manufacturing records for the device verified the lot met all pre-release specifications.The device was discarded, so an engineering investigation could not be conducted.

Event Description

On an unknown date in 2008, a patient was treated for an abdominal aortic aneurysm with a medtronic device.It was reported the device had migrated distally, so a reintervention was planned.On (b)(6) 2015, a reintervention procedure to re-line the previously implanted medtronic device was carried out.A gore® excluder® aaa endoprosthesis featuring c3® delivery system was utilized to re-line the previously implanted medtronic graft.The trunk-ipsilateral leg endoprosthesis was successfully deployed in the desired location.When the contralateral leg endoprosthesis was advanced, difficulty was experienced in cannulating the contralateral gate.It was decided to remove this device, and balloon the vessel, however during removal the stent became bunched and stacked on the catheter, and could not be used, so the artery was ballooned and a new contralateral leg endoprosthesis was advanced and deployed in the desired location and the patient did well following the procedure.

Manufacturer Narrative

A review of the event determined this event is not reportable since the compression observed was on an undeployed device.Additional device information related to initial report, for reference: (b)(4).

• 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 86004 ; 9285263030
• MDR Report Key: 4965757
• MDR Text Key: 23539362
• Report Number: 2953161-2015-00084
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 08/26/2015

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 Expiration Date: 03/31/2018
• Device Catalogue Number: PXC141400
• Device Lot Number: 13830002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2015
• 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: 70 YR