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

Catalog Number PXC141400

Device Problem Material Rupture (1546)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/13/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) additionally, the ifu states: adverse events that may occur and / or require intervention include but are not limited to: endoleak, occlusion of device or native vessel, claudication.Additionally, the ifu states: according to the gore excluder aaa endoprosthesis instructions for use, patients should be counseled as to the possibility of subsequent reinterventions including catheter based and open surgical conversion.

Event Description

On an unknown date in 2011 this patient underwent treatment for a right common iliac aneurysm with unknown endoprostheses.On (b)(6) 2012, the patient underwent reintervention to treat a type iv endoleak caused by a rupture of the previously placed ¿unknown¿ endoprosthesis.A gore excluder contralateral leg component was advanced within the previous ¿unknown¿ endoprosthesis and landed just distal to the renal arteries.Two gore excluder contralateral leg components were then implanted side by side within the contralateral leg component and extended distally; relining each common iliac artery to a level just proximal of the hypogastric arteries on both the right and left side.On (b)(6) 2015, a distal type i endoleak from distal extremity of right branch of endoprosthesis in the right common iliac artery was determined.On (b)(6) 2015, the patient underwent reintervention and the right internal and external iliac arteries were implanted with a gore viabahn endoprosthesis to seal the distal neck, with success.The patient tolerated the procedure and was discharged on post operative day three.The endoleak is reported to be caused by aneurysmal disease progression.Control image shows no endoleaks, but the asymptomatic occlusion of right internal iliac artery.

Manufacturer Narrative

Please reference field for results of imaging evaluation.

Manufacturer Narrative

Corrected/additional information.

• 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 WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: laura crawford ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5505511
• MDR Text Key: 40534697
• Report Number: 2017233-2016-00247
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: PXC141400
• Device Lot Number: 9707517
• 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: 10/27/2011
• 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: 50 YR
• Patient Weight: 95