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

Model Number FA-71400-25

Device Problems Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Treatment of a large aneurysm measuring approximately 17mm located in the supraclinoid segment of the left ica (internal carotid artery).The patient was on dual anti-platelet therapy.The anatomy of the patient was very tortuous, so the physician decided to use a triaxial system with the tip of the distal access catheter very close to the proximal edge of the neck of the aneurysm in order to have more support.As the physician inserted the pipeline inside the marksman catheter and the pipeline was passing the more tortuous segment, there was great resistance experienced.The physician was able to push the pipeline out of the catheter and began to deploy it, but it could not be released from the capture coil despite several rotations.The physician decided to remove the entire system (marksman catheter and pipeline) from the patient through the distal access catheter and the pipeline opened itself inside the access catheter.The patient was in good condition.

Manufacturer Narrative

The device involved in the event has not been returned for evaluation.(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: 3666731
• MDR Text Key: 11586701
• Report Number: 2029214-2014-00122
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FA-71400-25
• Device Lot Number: 9646787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: No
• 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: 59 YR
• Patient Weight: 60