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

Model Number PED-500-12

Device Problem Activation Failure (3270)

Patient Problem Vasoconstriction (2126)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the two pipeline devices failed to open.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the paraophthalmic section of the right ica.The max diameter was 4.18mm, and the neck diameter was 4.28mm.The patient's vessel tortuosity was minimal.The landing zone was 4.18mm distal and 4.87mm proximal. dual antiplatelet treatment was administered, and the pru level was 60.It was reported that the doctor attempted to deploy the (b)(4) as per the instructions for use (ifu), but it did not open.The distal portion slightly opened but was severely flat around the genu.The physician attempted to resheath and center the device, and had the navien catheter in the vertical petrous segment.After several attempts, the doctor pulled out the device along with the  marksman catheter.The doctor replaced the marksman and downsized the pipeline to a (b)(4).They attempted to open in the middle cerebral artery segment (mca), but the pipeline did not open distally or "cigared" where the middle portion would open.The physician pushed the wire more than 50% with both devices when they failed to open.After noticing spasm in the mca segment during an angiogram, the doctor decided to not risk further potential harm.They plan on attempting flow diversion with another flow diverter.It was noted that the proximal, middle, and distal portions of both pipelines failed to open.The middle part of the pipeline had been placed in a bend, and the physician had resheathed them more than 2 times.The doctor had attempted to reposition the devices in a straight segment, but they still failed to open.Both devices were removed from the patient. angiographic results post procedure were said to be poor and showed that vasospasm occurred. the patient outcome was alive with no injury.The devices were prepared according to the ifu.Ancillary devices include a ballast 088 long sheath, navien.058 guide catheter, marksman microcatheter, and synchro standard guidewire.

Manufacturer Narrative

H3: the pipeline flex was returned for evaluation.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.The distal and proximal ends of the pipeline flex braid were fully opened and moderately frayed.No bend found 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 returned device, the pipeline flex was not confirmed to have failure to open issue.The root cause could not be determined as the distal and proximal ends of pipeline flex braid were fully opened and moderately frayed.The damage to the braid on the ends of the pipeline flex braid is likely the results of the physician re-sheathing the device more than recommended two times.Possible causes include patient tortuous anatomy and damaged to the pipeline flex braid.There was no non-conformance to specifications identified that led to the failure to open issue.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.Resheathing 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.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex embolization device.Re-sheathing the pipeline flex 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.¿ 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: 11780524
• MDR Text Key: 249264639
• Report Number: 2029214-2021-00543
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016897
• UDI-Public: 00847536016897
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2024
• Device Model Number: PED-500-12
• Device Catalogue Number: PED-500-12
• Device Lot Number: B158206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 106