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

Model Number PED-500-30

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Monitoring and trending this type of event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the pipeline flex pushwire separated during deployment.The separation was alleged to have occurred at the proximal marker.The device and the separated section were reported to have been retrieved.A new pipeline device was used to treat the patient.The devices were prepared and used per the instructions for use (ifu).The patient was undergoing treatment of a left internal carotid artery (ica), unruptured aneurysm.The neck was 7 mm.The distal landing zone was 3.9 mm and the proximal 4.9 mm.The vessel anatomy was moderate in tortuosity.The separation occurred during the resheathing of the device.The physician noted that he did not feel movement and realized it had separated inside the distal portion of the catheter.At the time of the observation, only about 1/3rd of the device had been deployed prior to resheathing.The entire system was removed and nothing remained in the patient.Resistance was not experienced when the pipeline was advanced through the phenom.Only resheathing attempt was when the separation occurred.Resheathing was abandoned and the device and all parts of the delivery system was retrieved.The device was partially deployed in m1, dragged through distal ica as per normal technique.The device and all delivery segments were captured by advancing the phenom plus over and withdrawing phenom 027.

Manufacturer Narrative

D10.Device available, return date - additional information g4.Date manufacturer received - additional information g7.Type of report - additional information h2.Follow-up type - additional information h3.Device evaluation, device returned - additional information h6.Evaluation codes - additional information, device evaluation h10.Additional manufacturer narrative - additional information, device evaluation the pipeline flex device was returned within its inner pouch.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 pushwire appeared to be separated at the distal hypotube.The distal and proximal ends of the pipeline flex braid were found fully opened and moderately frayed.No bend was observed on the pushwire.No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No other anomalies were observed.The broken end of the pushwire was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) analyses.Based on the analysis findings, the pipeline flex was confirmed to have pushwire separation issue.The pushwire was separated at the distal hypotube.Per the sem results, "most of the fracture surfaces exhibit corrosion damage that obscured the origin fracture features.It is not possible to determine the failure mode based on the testing performed." 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 EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10178695
• MDR Text Key: 199465733
• Report Number: 2029214-2020-00574
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536019782
• UDI-Public: 00847536019782
• 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: 07/31/2020

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: 07/22/2022
• Device Model Number: PED-500-30
• Device Lot Number: A869087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/14/2020
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1