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

Model Number FA-77500-16

Device Problems Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2014

Event Type  Injury  

Event Description

Treatment of a large unruptured saccular aneurysm measuring 20 mm located in the cavernous segment of the left ica (internal carotid artery).On (b)(6) 2014, the patient underwent pipeline embolization treatment.The patient was on dual anti-platelet therapy.During the procedure it was reported that the proximal segment of the pipeline (5.0 mm x 16 mm) was not fully opposing the vessel wall and balloon angioplasty (an option presented in the instructions for use, u.S.) was performed to achieve full wall apposition.Post procedural angiogram showed an eclipse and slow flow into the aneurysm.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: 3695941
• MDR Text Key: 18311344
• Report Number: 2029214-2014-00176
• 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: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/05/2016
• Device Model Number: FA-77500-16
• Device Lot Number: 9798318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2013
• 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: 76 YR