MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FA-71425-30

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

The physician's name was not provided.The pipeline device has not been returned for evaluation.The event could not be confirmed.The event cause could not be determined from the reported information.

Event Description

Medtronic received report that a pipeline device was stuck in the capture coil during a procedure.The patient's anatomy was severely tortuous.It was reported that a microcatheter was placed and the physician advanced a pipeline device.At deployment of the pipeline out of the microcatheter, the "head part" did not open.The physician had difficulty pushing or withdrawing the system due to severe vessel tortuosity.The physician rotated the pipeline push wire seven times, but the pipeline could not be released from the tip coil.Finally, the physician removed the microcatheter and pipeline from the patient.Outside of the patient, the physician was able to release the pipeline.A new device was used to complete the procedure without issue.The patient is currently stable.There was no report of patient injury as a result of this event.

Event Description

Medtronic received additional event information: the patient was undergoing treatment for an unruptured, giant, saccular aneurysm in the right internal carotid artery (ica).The aneurysm had a max diameter of 9.74mm and neck width of 10.79mm.Landing zone artery size was 3.98mm proximal and 4.27mm distal.All catheters were flushed with heparinized saline.

Manufacturer Narrative

Device evaluation: the pipeline embolization device was returned for evaluation.As received, the pipeline was inside the catheter with an rotating hemostatic valve (rhv) attached to the catheter hub and a torque device attached to the proximal section of the pipeline delivery system.The pipeline braid was found to be partially deployed out of the catheter tip and released from the capture coil.For further examination, the rhv and the torque device were removed from the catheter and pipeline delivery system assembly.The pipeline braid was found to be fully open with moderate fraying at the distal and proximal end and no damages in the middle.Based on the analysis findings and the reported event details, the report that the pipeline was stuck in the capture coil could not confirmed.No damages were found with the capture coil and the pipeline braid.The cause for the reported event could not be determined.It¿s possible that the patient's "severe vessel tortuosity¿ may have contributed to the reported issue.Pipeline instructions for use (ifu) provides the following guidance: ¿do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 5519757
• MDR Text Key: 40962718
• Report Number: 2029214-2016-00158
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2018
• Device Model Number: FA-71425-30
• Device Lot Number: A157205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2015
• 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 Age: 00060 YR
• Patient Weight: 55