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

Model Number PED2-350-18

Device Problem Activation Failure (3270)

Patient Problem Fistula (1862)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the pipeline flex with shield did not open in the middle and proximal sections.During attempt to open the device, a carotid cavernous fistula (ccf) was noted to have developed.The ped2¿s middle section was placed in a bend.More than 50% of the device was deployed when the event occurred.The device was sheathed less than or equal to 2 times.No additional steps were made to open the device.The device was not removed and was implanted in the patient.Full wall apposition was not achieved.A balloon was not used to attempt in opening the device.The ped2 was deployed in internal carotid artery (ica) and opening well distally in communicating segment and across aneurysm neck.However, it was not flaring around clinked bend and into cavernous segment.Resheathed and redeployed slightly more distally; improved opening but still not normal.Resheathed a second time and redeployed again with staged adjustment of catheter tension/ braid delivery- same appearance of non-opening proximally.With manipulation the phenom tip had was between deployment and resheathing marker.Attempted to recapture the braid a final time and the ped deployed.It opened proximally but had a waisted mid-section.It was not possible to pass through with phenom microcatheter.Left ica injection confirmed good cross flow.Further manipulation of navien and phenom to get through ped.A carotid cavernous fistula (ccf) was visible on next run.The right ica was occluded with coil.Post the procedure, the patient was reported to be neurologically intact on extubated.The devices were prepared and used per the instructions for use (ifu).The catheter was flushed as indicated in the ifu.The patient was on dapt.The angiographic result post procedure was acceptable.The patient was being treated for a right paraophthalmic, unruptured aneurysm that was fusiform.The max diameter was 6mm with a neck width of 3mm.The landing distal zone was 3.2mm and the proximal was 3.7mm.The vessel anatomy was moderate in tortuosity.

Manufacturer Narrative

The pipeline flex pusher and the catheter were returned.The pipeline flex with shield was not returned as it was implanted.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.No other anomalies were observed.Based on the analysis findings and the customer's photos, the pipeline flex with shield was confirmed to have failure to open at the middle section.The customer reported that the patient vessel tortuosity was moderate.In addition, the middle section of the pipeline flex with shield was placed in a bend.It is possible that the patient vessel tortuosity may have contributed to the reported events.Vessel damage is a known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).Since, the pipeline flex with shield braid was not returned, any contributing factor of the braid to the issue could not be determined.No damages were found with the returned pusher and catheter.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.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 embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device.Re-sheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device.Carefully inspect the deployed pipeline flex embolization device under fluoroscopy to confirm that it is completely apposed 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.¿ 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 WITH SHIELD
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8424686
• MDR Text Key: 139329851
• Report Number: 2029214-2019-00213
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2020
• Device Model Number: PED2-350-18
• Device Lot Number: A449566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR