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

Model Number FA-77350-18

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Headache (1880); Visual Impairment (2138)

Event Date 02/04/2014

Event Type  Injury  

Event Description

Treatment of a large unruptured saccular aneurysm measuring approximately 18mm x 3.00mm located in the ophthalmic 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 involving two pipelines.During the procedure, it was reported the first pipeline (3.50mm x 18mm) was implanted in the patient without issues.The second pipeline (3.50mm x 10mm) could not be released from the capture coil and was removed from the patient.On the same day following the procedure, the patient experienced headaches and loss of vision.Post procedural angiogram showed slow flow into the aneurysm.On (b)(6) 2014, the patient was brought back and had another pipeline (3.50mm x 10mm) implanted without issues.On (b)(6) 2014, the patient's vision stabilized and she was discharged from the hospital.Same event as mdr# 2029214-2014-00112.

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: 3660311
• MDR Text Key: 15123664
• Report Number: 2029214-2014-00130
• 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: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/28/2016
• Device Model Number: FA-77350-18
• Device Lot Number: 9699008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2013
• 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: 54 YR