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

Model Number PED-475-30

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

Event reported in lieu of analysis results.Analysis of the pipeline flex embolization device (lot no.B129107) found that the pipeline flex pusher distal hypotube was stretched with the shrink tubing pulled back from the proximal bumper.The proximal bumper and resheathing pad were found in good condition.However, the pusher distal core wire was found broken.The phenom 27 catheter was examined.The phenom 27 catheter hub, catheter body, and distal tip were in good condition.However, the pipeline flex braid could be seen still within the catheter hub.The phenom 27 catheter was dissected (cut), and the pipeline flex braid, ptfe sleeves, and tip coil were removed from within the catheter hub.It was observed that the pipeline flex distal core wire broke at the ptfe sleeves.The ptfe sleeves and tip coil were found damaged.The pipeline flex braid ends were found open but damaged (frayed).The broken core wire was sent out for sem (scanning electron micrographic) analysis.Per the analysis report, the wire failed via torsional overload.Based on the device analysis and reported information, the customer¿s ¿resistance/stuck during delivery¿ report could not be confirmed.Based on the investigation conducted, resistance can occur during the device's tracking, deployment, and re-sheathing in distal and tortuous anatomies.It is possible the damage found with the pipeline flex braid or the patient¿s ¿moderate¿ vessel tortuosity contributed to the event.No damage was found with the returned phenom 27 catheter that would have contributed to the reported resistance issue.In addition, it was reported that a continuous flush was maintained.Therefore, the cause for the resistance could not be determined.Based on the formal investigation, separation can occur due to certain use conditions such as excessive force or patient vessel tortuosity.From the damages seen on the pipeline flex pusher (stretching), it appears excessive force may have been used.It is also likely that the reported resistance contributed to the separation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a pipeline which became stuck at the distal end of the phenom catheter.The patient was undergoing a procedure for flow diversion treatment of an unruptured saccular aneurysm of the left ophthalmic artery segment.The aneurysm max diameter was 10.21mm and the neck diameter was 8.77mm.Vessel tortuosity was moderate.It was reported that all devices were prepared according to the instructions for use (ifu).The phenom was navigated smoothly and in place in the m2 and the pipeline was delivered smoothly.In the m1 segment, the pipeline distal tip opened well.Pulling back and p ositioning was going well.However, it was found during the delivery that the pipeline could not be pushed out further and the phenom catheter also could not be withdrawn to deploy the pipeline.The physician attempted to release the stack in the system but it did not resolve the resistance.After repeated attempts, there was no change and the pipeline remained stuck in the distal end of the catheter.The phenom catheter and the pipeline were withdrawn together from the patient's body and it was found that the two devices were stuck together and could not be separated.It was noted that the catheter was flushed continuously with heparinized saline during the procedure.Both devices were replaced to complete the procedure.There was no harm or injury to the patient.Post-procedure angiography showed that all blood vessels were normal.There was no thrombotic event.The surgery was very successful with no effect from the event.Additional information received reported that there was no damage observed to that phenom catheter or the pipeline device.

Manufacturer Narrative

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: 12454345
• MDR Text Key: 271647991
• Report Number: 2029214-2021-01151
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016804
• UDI-Public: 00847536016804
• 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: 09/21/2021

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: 12/08/2023
• Device Model Number: PED-475-30
• Device Catalogue Number: PED-475-30
• Device Lot Number: B129107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 53