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

Model Number PED2-500-18

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Difficult to Open or Close (2921); Activation Failure (3270)

Patient Problems Stenosis (2263); No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation yet; therefore, the event cause could not be determined.The device is in the process of being shipped back for evaluation.Once the device has been received and evaluation, a supplemental report will be submitted.For the first pipeline, please refer to the mdr# 2029214-2018-00680.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the distal segment of the medtronic flow diverter would not open as it was deployed and had to be opened by balloon angioplasty.There was no friction or difficulty delivering this flow diverter to the intended location.The middle segment was positioned on a bend.There was stenosis observed so it was decided to balloon angioplasty the section and deploy the second medtronic flow diverter through this section.Upon deploying the second flow diverter more than 50%, the distal and middle section of the flow diverter would not open and started to flatten out.The flow diverter was resheathed and deployed again two times with the same problem occurring.It was noted that the proximal and distal segment of the flow diverter was positioned on a bend.The second flow diverter was then resheathed and removed from the patient.A third medtronic flow diverter was then deployed without any issues.A carotid stent was also deployed through the stenosis.Post procedural angiography showed a good result with stasis in aneurysm and all stents.The multiple stents were needed due to the stenosis.The patient¿s anatomy was noted to be severely tortuous.No patient injury was reported as a result of the event.The patient was undergoing embolization of an unruptured amorphous aneurysm measuring 8mm x 6mm located in the cavernous segment of the left internal carotid artery (ica).The distal and proximal landing zone was 4.3mm by 5mm.The patient was administered dual antiplatelet treatment (dapt), but the pru level was not known.A continuous flush was maintained during the procedure.The pushwire of the first medtronic flow diverter will not be returned.The second medtronic flow diverter is in the process of being returned.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The pipeline flex with shield was returned for evaluation and the distal and proximal ends of the pipeline flex shield braid appeared fully opened with moderately frayed.No other anomalies were observed.The product analysis does not indicate a potential or confirm manufacturing issue; therefore, no lot history record review is required.Based on the analysis findings, the customer reports of "failure to open at the distal end" and "failure to open at the middle section" were not confirmed as the pipeline flex shield braid appeared fully opened with moderately frayed at both ends.The customer reported that the patient's vessel tortuosity was severe, and the device was deployed on a bend.It's possible that the patient's vessel tortuosity and damaged braid may have contributed to the reported issues.It is not recommended to initiate the deployment of the device on the bend.The damage to the braid on the ends of the pipeline flex shield is likely the results of the customer re-sheathing the device more than recommended two times.All products are 100% inspected for damage and irregularities during manufacture.Per our instructions for use (ifu): "begin to deliver the device using a combination of unsheathing the pipeline flex shield embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex shield has successfully expanded, deploy the remainder of the device.Carefully inspect the deployed pipeline flex shield 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.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex embolization device.Re-sheathing the pipeline flex shield embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.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.¿ if information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• 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 ; 9496801224
• MDR Report Key: 7733870
• MDR Text Key: 115772828
• Report Number: 2029214-2018-00681
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2020
• Device Model Number: PED2-500-18
• Device Lot Number: A419003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 09/14/2018
• Supplement Dates FDA Received: 10/03/2018; 10/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2017
• 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
• Patient Age: 75 YR