MAUDE Adverse Event Report: EV3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE; FLOW DIVERSION

Model Number FA-77425-18

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2014

Event Type  malfunction  

Event Description

Treatment of a giant wide neck aneurysm located in the cavernous segment of the left ica (internal carotid artery).On (b)(6) 2014, the patient underwent pipeline embolization treatment.During the procedure, it was reported two pipelines (4.75mm x 20mm; 4.25mm x 18mm) could not be released from their capture coils despite several attempts and both devices were removed from the patient.A third pipeline was implanted without issues.No patient injury was reported as a result of the procedure.Same event as mdr 2029214-2014-00162.

Manufacturer Narrative

The pipeline and pushwire were returned for evaluation without the marksman catheter as it was discarded.The evaluation could not determine the cause of the event as the pipeline was found released from the capture coil and fully open; however, the capture coil and braid were found damaged and may have contributed to the reported issue.All devices are 100% inspected for damages and irregularities during manufacture.(b)(4).

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: FLOW DIVERSION
• Manufacturer (Section D): EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: henry to ; 9775 toledo way; irvine, CA 92618 ; 9496801335
• MDR Report Key: 3698496
• MDR Text Key: 4233379
• Report Number: 2029214-2014-00161
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/18/2017
• Device Model Number: FA-77425-18
• Device Lot Number: 9856431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2014
• 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