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

Catalog Number PLC161000

Device Problems Collapse (1099); Malposition of Device (2616); Patient-Device Incompatibility (2682); Deformation Due to Compressive Stress (2889)

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

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), additional considerations for patient selection include but are not limited to the patient¿s anatomical suitability for endovascular repair.The ifu further states, adverse events that may occur and/or require intervention include, but are not limited to improper component placement.

Event Description

On (b)(6) 2017, the patient underwent endovascular treatment of an abdominal aortic aneurysm with two gore® excluder® aaa endoprostheses.According to the report, during the implantation procedure the aorta dissected, with the dissection reportedly extending distally into the right common iliac artery.Reportedly, the dissection created compression of the contralateral gate and made cannulation the gate more challenging.Further, it was reported, due to gate compression, the contralateral leg component was placed lower in the gate than intended.It was reported, additional ballooning was performed within the gate.According to the report, the procedure concluded without any further complications and final angiography showed exclusion of the aneurysms with patency of all devices.On (b)(6) 2017, follow-up imaging identified device lumen narrowing/compression of the contralateral leg component within the contralateral gate.No evidence of thrombus within the device was identified and the device was reported to be patent without evidence of occlusion.The device compression is reportedly due to the lower placement of the device within the gate at the time of deployment.According to the report, an intervention was performed on (b)(6) 2018, to treat the device compression.It was reported, two gore® viabahn® vbx balloon expandable endoprostheses were implanted to reline the contralateral leg component and restore radial force to the vascular wall.The device compression was reported to have been resolved with no further adverse events reported.It was reported the patient tolerated the procedure.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: charlene cooper ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7246163
• MDR Text Key: 99181662
• Report Number: 3013164176-2018-00006
• 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: Physician
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2020
• Device Catalogue Number: PLC161000
• Device Lot Number: 17155809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2017
• 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; Required Intervention
• Patient Age: 75 YR