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

Model Number FA-77500-14

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 07/22/2014

Event Type  Injury  

Event Description

Treatment of a small saccular unruptured aneurysm measuring 5mm located in the cavernous segment of the left ica (internal carotid artery).The patient was given dual anti-platelet therapy.On (b)(6) 2014, the patient underwent pipeline embolization treatment.During the procedure, it was reported the pipeline (5mm x 14mm) released from the capture coil after rotating the pushwire more than ten times and also by manipulating the pushwire by pushing and pulling it.Post procedural angiogram showed an eclipse.The patient was reported to be doing fine and the physician was pleased with the results post deployment.

Manufacturer Narrative

The marksman and pushwire were returned for analysis without pipeline as it was implanted in the patient.The evaluation could not determine the cause of the event as the pushwire was returned without the pipeline; however, the capture coil was found to be damaged and may have contributed to the reported event.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: michael nguyen ; 9775 toledo way; irvine, CA 92618 ; 9496801558
• MDR Report Key: 4036881
• MDR Text Key: 4849299
• Report Number: 2029214-2014-00483
• 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: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/04/2014
• Device Model Number: FA-77500-14
• Device Lot Number: 9669049
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2011
• 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 Outcome(s): Disability
• Patient Age: 52 YR