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

Model Number FA-77425-14

Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 03/05/2014

Event Type  Injury  

Event Description

Treatment of a small blister aneurysm located in the para ophthalmic segment on the left ica (internal carotid artery).On (b)(6) 2014, the patient underwent pipeline embolization treatment.The patient was given standard medications.During the procedure, the first pipeline (4.25 mm x 16 mm) could not be released from the capture coil and only one long strand remained attached.The second pipeline (4.25 mm x 16 mm) did not open at the distal end to the nominal diameter (4.25 mm) and the middle portion of the pipeline remained tightly wrapped on the delivery wire.The third pipeline (4.25 mm x 12 mm) could not be released from the capture coil and flattened around the bend as it was attempted to be deployed.The fourth pipeline (4.25 mm x 14 mm) did release from the capture coil but would not open and continued to flatten instead of opening.Many attempts were made to open the pipelines by using several common deployment techniques but was unsuccessful.All four pipelines were removed from the patient.Patient is in stable condition.Reference mdr 2029214-2014-00182 / 2029214-2014-00184 / 2029214-2014-00185.

Manufacturer Narrative

The pipeline was returned for evaluation without the pushwire.The evaluation could not determine the cause of the event as the pipeline was found fully opened; however, it is likely that the damaged braid likely contributed to the reported issue.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: 3715294
• MDR Text Key: 17928540
• Report Number: 2029214-2014-00183
• 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: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/24/2016
• Device Model Number: FA-77425-14
• Device Lot Number: 9820784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2013
• 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): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 150