MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-375-35

Device Problems Difficult To Position (1467); Activation Failure (3270)

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

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation; therefore, the event cause could not be determined.Correspondence has been sent out for the return of the device.Once it is received and the evaluation is complete, a supplemental will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that after the medtronic microcatheter was put in place, the medtronic flow diverter was smoothly advanced to the distal artery of the aneurysm.The distal tip was not opening smoothly due to the tortuous vessels, but eventually opened after repeated manipulations and adjustments.The distal tip of the medtronic flow diverter was 6mm at the distal end of the aneurysm.The physician continued to release the medtronic flow diverter in the middle of the neck of the tumor; however, the whole system fell into the aneurysm sac due to the tortuosity and excessive tension.The physician had to withdraw the medtronic flow diverter and replace it with another medtronic flow diverter for the same type to complete the operation.There was no patient injury reported as a result of the event.The patient was undergoing embolization of an unruptured saccular aneurysm measuring 17mm x 15.5mm located in the ophthalmic segment of the internal carotid artery (ica).Access vessel is unknown.The distal and proximal landing zone was 3.04mm x 3.76mm.The patient¿s vasculature was severe in tortuosity.The patient was on dual antiplatelet therapy (dapt) the pru level was unknown.The microcatheter was flushed and prepared as indicated in the ifu.There was no damage observed on the devices prior to use.

Manufacturer Narrative

The pipeline flex delivery system was returned for evaluation with the distal and proximal ends of the pipeline flex braid fully opened with no damage.No other anomalies were observed.Based the analysis the customer report of ¿failure to open at the distal end¿, the event cause could not be determined as the distal and proximal ends of the pipeline flex braid was found fully opened.The customer reported that the patient¿s vessel tortuosity was severe.It¿s possible that the ¿severe vessel tortuosity¿ may have contributed to the reported issues.Per our instructions for use (ifu): "begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex has successfully expanded, deploy the remainder of the device.Carefully inspect the deployed pipeline flex embolization device under fluoroscopy to confirm that it is completely opposed to the vessel wall and not kinked.If the device is not fully apposed or is kinked, consider using a balloon catheter, micro catheter, or guide-wire to fully open it.Do not use in patients in whom the angiography demonstr ates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ no evidence was found to suggest that the device failed to meet specifications; therefore, manufacturing has been ruled out as a potential cause.The investigation determined that this was a known event.Therefore, no new formal investigation was required.Failure to open and the patient tortuous anatomy are common sequences of events and contributing factors that can lead to this known event are documented in the risk management file.All products are 100% inspected for damage and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7558834
• MDR Text Key: 109749530
• Report Number: 2029214-2018-00468
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S011
• 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
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2020
• Device Model Number: PED-375-35
• Device Lot Number: A567828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2017
• 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