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

Model Number FA-71400-30

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Thrombus (2101)

Event Date 03/11/2014

Event Type  Injury  

Event Description

Treatment of a large unruptured saccular aneurysm measuring 14 mm x 6 mm located in the cavernous segment of the left ica (internal carotid artery).The patient was on dual anti-platelet therapy.On (b)(6) 2014, the patient underwent pipeline embolization treatment.During the procedure, it was reported that the pipeline (4.0 mm x 30 mm) did not fully oppose the vessel wall and balloon angioplasty (an option presented in the instructions for use, us) was performed to achieve full wall apposition.A thrombus formed within the pipeline but it was treated with intergrillin.Post procedural angiogram showed an eclipse.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 implanted in the patient.(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: 3714809
• MDR Text Key: 18859209
• Report Number: 2029214-2014-00190
• 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: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/30/2016
• Device Model Number: FA-71400-30
• Device Lot Number: 9700184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR