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

Catalog Number PXC141400

Device Problems Break (1069); Premature Activation (1484); Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 05/27/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient was implanted with a system of gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.During the procedure, a trunk-ipsilateral component was deployed as planned.However, the physician encountered difficulty cannulating the contralateral gate.According to the report the patient¿s anatomy was extremely tortuous, and the sheath could not be advanced to the level of the contralateral gate.During the attempt to cannulate the gate, the contralateral leg component (pxc141400/12426768) reportedly had become caught on the distal end of the sheath, causing the deployment string to break and the device to prematurely deploy in the left common iliac artery.The left hypogastric artery was unintentionally covered by the device.The physician was able to implant an additional contralateral limb to bridge the space between the contralateral gate and the prematurely deployed device.The procedure was concluded without any further reported complications, and the patient tolerated the procedure.

Manufacturer Narrative

A review of the manufacturing paperwork for the devices verified that the lots met all pre-release specifications.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to improper endoprosthesis component placement and occlusion of native vessel.The gore® excluder® aaa endoprosthesis ifu states ¿do not advance the device outside of the sheath.The sheath will protect the device from catheter breakage or premature deployment while tracking it into position.¿.

• 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: damon jackson ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3869706
• MDR Text Key: 4457693
• Report Number: 2953161-2014-00071
• 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: 05/27/2014

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: 02/28/2017
• Device Catalogue Number: PXC141400
• Device Lot Number: 12426768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2014
• 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: 66 YR