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

Model Number FA-77500-20

Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2014

Event Type  malfunction  

Event Description

Treatment of an aneurysm measuring approximately 9mm located in the right ica (internal carotid artery).The patient was given aspirin and plavix prior to the procedure.On (b)(6) 2014, the patient underwent pipeline (5.00mm 20mm) embolization treatment.During the procedure, it was reported the physician attempted to open the pipeline in the right mca (middle cerebral artery) with approximately 3mm of it unsheathed but it could not be released from the capture coil despite repeated attempts.The device and catheter were removed from the patient.Another device was used to complete the procedure without issues.No patient injury was reported as a result of the procedure.

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it was discarded.(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: 3682414
• MDR Text Key: 17611637
• Report Number: 2029214-2014-00145
• 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: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/13/2014
• Device Model Number: FA-77500-20
• Device Lot Number: SE11-013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2011
• 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 Age: 49 YR