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

Model Number FA-77450-18

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/04/2014

Event Type  Injury  

Event Description

Treatment of a large unruptured saccular aneurysm measuring 22 mm x 9 mm located in the c7 (communicating segment) of the left ica (internal carotid artery).Prior to the treatment the patient was not on dual anti-platelet therapy.Patient was given dual anti-platelet therapy post procedure.On (b)(6) 2014, the patient underwent pipeline embolization treatment.During the procedure, it was reported that the pipeline (4.5 mm x 18 mm) did not open properly at the proximal portion.The guidewire was removed from the pipeline and access could not be regained despite attempts with different guidewires.The physician attempted to gain access for approximately 8 hours.The physician used almost a 1 liter of contrast and the patient had low blood pressure.The pipeline was removed from the patient using a microsnare kit.Following the procedure, the patient was in icu (intensive care unit) for several days.One week later, the physician used coils in the same aneurysm.

Manufacturer Narrative

The device involved in the event has not been returned for evaluation.(b)(4).

Manufacturer Narrative

There should not be an implant date as the device was removed from the patient with a microsnare.(b)(4).

Manufacturer Narrative

The pipeline was returned for evaluation without the pushwire and catheter.One end of the pipeline was found fully opened with damaged braid, while the other end was closed with damaged braids.The evaluation could not determine the cause of the event; however, the pipeline braid was found damaged and may have contributed to the reported event.All devices are 100% inspected for damages and irregularities during manufacture.(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: 3719077
• MDR Text Key: 4331283
• Report Number: 2029214-2014-00197
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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,Followup
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/24/2016
• Device Model Number: FA-77450-18
• Device Lot Number: 9766518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 74 YR