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

Model Number FA-77375-14

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Treatment of a right ica (internal carotid artery) aneurysm.During the procedure, it was reported the pipeline could not be released from the capture coil.The entire system (pipeline and marksman catheter) was removed from the patient without issues.The patient was in fine condition.

Manufacturer Narrative

The device involved in the event has not been returned for evaluation.(b)(4).

Manufacturer Narrative

(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: 3666813
• MDR Text Key: 4344920
• Report Number: 2029214-2014-00121
• 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,Followup
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FA-77375-14
• Device Lot Number: 9727623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2014
• Initial Date FDA Received: 03/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2013
• 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