MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number RLT311415J

Device Problems Use of Device Problem (1670); Unintended Movement (3026)

Patient Problems Aneurysm (1708); No Code Available (3191)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.(b)(4).Additional information, the date of event and the images were requested but were not available.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.Gore recommends that the gore® excluder® aaa endoprosthesis diameter be at least 2 mm larger than the aortic inner diameter (10 ¿ 21% oversizing) and 1 mm larger than the iliac inner diameter (7 ¿ 25% oversizing).According to the gore® excluder® aaa endoprosthesis instructions for use, sizing guide, the rlt311415j is intended to be used in aortic diameters ranging from 27-29mm.Reportedly, the patient¿s proximal neck diameter pre-operatively was 23.4-26.7mm, while the post-operative infrarenal aortic diameter was 27.2-33.2mm.Device selection should be performed based on sizing guidelines provided.Excessive oversizing may lead to adverse events.The ifu states, adverse events that may occur and / or require intervention include, but are not limited to component migration, endoleak and aneurysm enlargement.Please note that the medwatch with mfr report # 3007284313-2019-00123 was emailed to fda on (b)(6) 2019 to cover the vessel dissection by sheath.

Event Description

On (b)(6) 2017, this patient underwent an endovascular repair of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.No issues were observed, and the patient tolerated the procedure.On an unknown date, follow-up imaging identified a distal migration of the trunk-ipsilateral leg component (distance: about 40mm), and subsequent a proximal type i endoleak and the aneurysm enlargement (amount unknown).The trunk portion reportedly fell into the aneurysm sac.It was reported that the patient¿s proximal neck diameter pre-operatively was 23.4-26.7mm, while the post-operative infrarenal aortic diameter was 27.2-33.2mm.On (b)(6) 2019, gore® excluder® aaa endoprosthesis aortic extender components and non-gore devices were implanted to extend the trunk portion proximally to repair the migration and the proximal type i endoleak.The endoleak was reportedly resolved.During the re-intervention, pertaining to a gore® dryseal flex introducer sheath (b)(4), the left access vessel (external iliac artery) was dissected, and therefore repaired with a bare metal stent.It was reported that where the dissection occurred in the external iliac artery had stenosis prior to the procedure; however its diameter was unknown.The patient tolerated the re-intervention.

Manufacturer Narrative

As the date of the type i endoleak and the aneurysm enlargement is unknown, the reintervention date 04/08/2019 will be used as an event date.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8563140
• MDR Text Key: 143532708
• Report Number: 3007284313-2019-00124
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

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: 05/06/2018
• Device Catalogue Number: RLT311415J
• Device Lot Number: 13852963
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR