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

Model Number PED-400-25

Device Problem Positioning Problem (3009)

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

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

The pipeline device will not be returned for evaluation as it was implanted in the patient.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information a report of pipeline flex movement during placement.The patient was undergoing embolization treatment for a small unruptured saccular aneurysm located in ophthalmic segment, measuring 8mmx5mm, landing zone distal 2.7mm proximal 3.9mm.The vessel was observed severely tortuous.The catheter was flushed as indicated in the ifu.It was reported that this was a left para ophthalmic segment aneurysm planned for flow diverter.The microcatheter was placed in the distal m2 branch and pipeline 4x25 was taken through and started deploying just below the ica bifurcation.The distal landing was correct as per the plan just below the ica bifurcation.Continued to deploy the device slowly, while device started to open at the neck of the aneurysm, the distal device has fallen no adequate support of device was there above aneurysm neck.So physician decided to resheath the device.While resheathing the microcatheter along with device suddenly jumped into distal m2 segment.When physician tried to retrieve the device into microcatheter, only delivery wire of the device was seen moving into microcatheter and no movement in the device.Now physician had tried to pull the microcatheter and device together as a system , while pulling as a system the device could not be retrieved and got deployed form m2 to mid m1 of left ica.Now physician had deployed second device 4.25x25 by overlapping the first device and covered till the proximal segment of aneurysm.There were any patient symptoms or complications associated with this event.No patient injury was reported.

Manufacturer Narrative

The pipeline flex pusher and the headway 027 catheter were returned within the inner pouch; inside of a sealed bio-hazard bag and a shipping box.The pusher was found outside of the catheter.The pipeline flex braid was not returned as it was implanted.When compared to the drawings the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No bend was observed on the pusher.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.The total length of the catheter was measured to be 162.0cm.The catheter tip, the marker band and boy were examined; and no damages were found.No flash or voids molded were observed in the hub.The catheter was flushed with water and water exited out from the catheter tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter hub.The mandrel co uld pass through the catheter hub, lumen and tip with no issues.The catheter was found to be compatible for use with the pipeline flex delivery system as it has an inner diameter (id) of 0.027".No other anomalies were observed.Based on the analysis findings, the pipeline flex was not confirmed to have movement during deployment.No damages were found with the returned pusher and catheter.It is possible that the severe vessel tortuosity may have contributed to the reported issue.Since, the pipeline flex braid was not returned, any contributing factor of the braid to the issue could not be determined.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: 8480623
• MDR Text Key: 140885343
• Report Number: 2029214-2019-00281
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015968
• UDI-Public: 00847536015968
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2021
• Device Model Number: PED-400-25
• Device Catalogue Number: PED-400-25
• Device Lot Number: A648522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2019
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 68