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

Catalog Number PXC121400J

Device Problems Unintended Collision (1429); Malposition of Device (2616)

Patient Problem Occlusion (1984)

Event Date 07/14/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.After a trunk ipsilateral leg component (rmt231416j/13417562) was deployed, a delivery catheter of a contralateral leg component (pxc121400j/13412976) was advanced within the gate.An intra-procedure imaging was performed prior to deployment of the pxc121400j, revealing that the rmt231416j had moved distally, approximately 1cm below the renal arteries.The pxc121400j was deployed while the rmt231416j was being pushed up proximally, but the left internal iliac (liia) artery was unintentionally covered.A metal stent was implanted distally, and an aortic extender component was deployed for proximal extension.The procedure was concluded without any intervention being performed for coverage of the liia.The patient tolerated the procedure and has been monitored.It was reported that the rmt231416j moved distally, causing the pxc121400j to cover the liia unintentionally.As the access vessel was tortuous from the left common iliac artery to the left external iliac artery (s-curved vessel), the pxc121400j could not be pushed up during deployment.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Manufacturer Narrative

(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: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4934015
• MDR Text Key: 6012413
• Report Number: 2953161-2015-00079
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: PXC121400J
• Device Lot Number: 13412976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2015
• 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
• Patient Age: 77 YR