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

Model Number FA-77450-14

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Material Separation (1562)

Patient Problems Stroke/CVA (1770); Death (1802)

Event Date 12/10/2013

Event Type  Death  

Manufacturer Narrative

The pipeline will not be returned for evaluation as it was implanted in the patient.The broken pushwire segments have not been returned for evaluation.(b)(4).

Event Description

Treatment of a small aneurysm measuring 6mm x 5mm located on the posterior side of the p1.On (b)(6) 2013, the patient underwent pipeline embolization treatment.During the procedure, the pipeline (4.50mm x 14mm) was implanted without issues.Upon retrieving the distal wire into the marksman catheter, the distal wire separated.A 3mm alligator retrieval device was used to retrieve the broken segment from the p2.Some vasospasm was noticed following the retrieval of the wire and direct verapamil was given to resolve it.Post pipeline procedure, the patient was transferred from the icu (intensive care unit) to post-anesthesia care unit neurologically intact.On (b)(6) 2013, the patient expired.Ct (computed tomography) angiogram showed no signs of stroke or hemorrhage.The physician comments that the patient had cardiac complications from anesthesia and the cause of death is a heart attack.

• 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: 3563132
• MDR Text Key: 19454393
• Report Number: 2029214-2014-00007
• 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: 12/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/12/2016
• Device Model Number: FA-77450-14
• Device Lot Number: 9787840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2013
• 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): Death
• Patient Age: 55 YR