MAUDE Adverse Event Report: IRVINE PIPELINE EMBOLIZATION DEVICE; FLOW DIVERSION

Model Number FA-71450-35

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Capturing Problem (2891); Material Twisted/Bent (2981)

Patient Problems Aneurysm (1708); Tissue Damage (2104)

Event Date 09/05/2014

Event Type  Injury  

Event Description

Treatment of a giant aneurysm measuring 40mm located in the paraclinoid segment of the ica (internal carotid artery).The exact neck size was hard to determine due to the large aneurysm size, but it was approximately 25mm to 30mm.The anatomy of the patient was tortuous.The patient was given aspirin and plavix.On (b)(6) 2014, the patient underwent pipeline embolization treatment.During the procedure, it was reported the proximal segment of the pipeline (4.50mm x 35mm) became twisted as 80% of the pipeline was already deployed.The physician continued to deploy the pipeline with the twist still visible.Once the device was fully deployed, it took multiple tries to recapture the capture coil due to the size of tortuosity of the vessel.Multiple attempts to recapture the capture coil caused the distal segment of the pipeline to slightly foreshorten and fall into the aneurysm.A balloon was used to anchor and pull the distal portion of the pipeline out of the aneurysm and the balloon was also used to dilate the lumen of the pipeline (an option presented in the instructions for use, u.S.) and remove the twist.The pipeline was pulled out of the aneurysm into the cavernous segment and not fully covering the aneurysm neck.A balloon occlusion test was performed and there was enough contralateral flow.An amplatzer plug was deployed proximal to the pipeline and the carotid was sacrificed.The aneurysm was located in the sacrificed carotid; therefore, there are no future plans for treatment.On (b)(6) 2014, it was reported the patient was stable.

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it was implanted in the patient.(b)(4).

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: FLOW DIVERSION
• Manufacturer (Section D): IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: 9775 toledo way; irvine, CA 92618
• MDR Report Key: 4126106
• MDR Text Key: 17625833
• Report Number: 2029214-2014-00548
• 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: Invalid Data
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2016
• Device Model Number: FA-71450-35
• Device Lot Number: 9944470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2013
• 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; Disability
• Patient Age: 12 YR