MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-450-30

Device Problems Break (1069); Activation Failure (3270)

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

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has not been returned for evaluation; therefore, product analysis cannot be performed.The device was not returned; therefore, the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.Related mdrs for this event: 2029214-2019-01204.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that both pipeline flex devices did not open.The first pipeline pushwire broke.The patient underwent coiling treatment for an unruptured saccular aneurysm located left cavernous sinus aneurysm.Measuring 15.2mmx12.3mm, landing zone 3.5mm proximal 4.5mm.The vessel was observed severely tortuous.It was reported that aneurysm blood flow-oriented embolism was performed.After the catheter was in place, delivered 4.5-30 ped rele ased it.However, because of vascular tortuosity, the tip of ped released but not very good opened.The physician decided to retrieve and then release again, retrieved with big resistance.Finally, the pipeline was retrieved into the medtronic catheter, but found the pushwire of pipeline was separated, and the pipeline braid partly remained on catheter.As a result, it could only be retrieved as the entire system out of the patient¿s body.The catheter was placed again, and 4.5-35 pipeline release was selected, but the tip of pipeline could not be pushed or opened due to the same problem (pli 20, 30).The surgeon was afraid that the instrument would damage the patient's blood vessels, so he removed the whole system from the body.Replaced with 4.25-35 and it could be released and opened and fitted the blood vessel wall successfully.There were no reports of patient injury in association with this event.

Manufacturer Narrative

The pipeline flex was found stuck inside the catheter.The pipeline flex could not be pushed forward or removed from the catheter.For further examination, the catheter was cut to remove the pipeline flex.The pipeline flex pushwire appeared to be separated at proximal to the dps sleeves.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact and fully opened with no signs of damage.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the pipeline flex braid were found fully opened and moderately frayed.Bends were found on the pushwire.No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The broken end of the pipeline flex were sent out for sem/eds analyses.Based on the analysis findings and sem/eds analysis, the pipeline flex and catheter were confirmed to have resistance during delivery and pushwire separation.The fracture surface exhibits dimple features consistent with torsional overload failure mechanism.However, the pipeline flex failure to open was not confirmed as the returned pipeline flex braid appeared to be fully opened and moderately frayed at both ends.From the damages seen on the catheter body (accordioning), pusher (bending), pipeline flex braid (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the attempted to advance the pipeline flex through the marksman catheter against resistance.It is likely that the severe vessel tortuosity may have contributed to the failure to open, resistance during delivery and pushwire separation issues.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9419486
• MDR Text Key: 208758899
• Report Number: 2029214-2019-01203
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: PED-450-30
• Device Lot Number: A815065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR