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

Model Number FA-77425-20

Device Problems Detachment Of Device Component (1104); Difficult to Insert (1316); Physical Resistance (2578)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/27/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Treatment of a large unruptured saccular aneurysm measuring 18mm x 11mm located in the cavernous segment of the right ica (internal carotid artery).Dual anti-platelet (aspirin and plavix) therapy was given.Heparin was given intra-operatively.The vasculature was very tortuous.On (b)(6) 2014, the patient underwent pipeline embolization treatment.During the procedure, it was reported the mca (middle cerebral artery) was accessed after a very long catheterization and the device was delivered to the tip of the catheter with great resistance.Once the pipeline was unsheathed approximately 4mm, the system was pulled into the straight supraclinoid section to be released, but it would not release from the capture coil despite multiple attempts.The pipeline eventually released from the capture coil after approximately 30 minutes of additional manipulation and it was delivered.As the proximal end of the pipeline was pushed out and unsheathed, it would not open.It appeared to be pinched closed.The system was manipulated multiple times in an attempt to open the proximal end, but the delivery wire was moving backwards and they were in danger of losing access.In a final attempt, the catheter was pushed through the proximal end and it opened.It was then observed that the proximal end had fallen into the aneurysm.Attempts were made to regain access, but the catheter kept bunching up in the aneurysm and the distal end of the pipeline also fell into the aneurysm after the multiple attempts.The procedure was aborted and post procedural angiogram showed the device remained in the aneurysm wedged between the walls and not obstructing the in-flow or out-flow.On (b)(6) 2014, the patient was reported to be doing fine and will return approximately one month post procedure for a second attempt.

Manufacturer Narrative

The device will not be returned for analysis as it remains 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: 3892085
• MDR Text Key: 12026632
• Report Number: 2029214-2014-00351
• 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,Followup
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/21/2014
• Device Model Number: FA-77425-20
• Device Lot Number: OC11-047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2011
• 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): Required Intervention; Disability
• Patient Age: 66 YR