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

Model Number PED2-350-30

Device Problem Break (1069)

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

Event Date 08/05/2019

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 receive report that after the uneventful navigation and deployment of the pipeline flex, when an attempt was made to raise microcatheter to collect the sleeve.The delivery pusher was unable to be pulled in the middle.The delivery pusher was pulled, and movement of the wire could not be found, so it was judged that the wire had broken.However, the delivery pusher was almost retracted in microcatheter, and the delivery pusher was pulled out together with marksman.The delivery pusher was removed from microcatheter outside the body, and the breakage was confirmed visually.The break was in the proximal section of the pushwire.There was no resistance felt during the use of the devices.This event occurred during the treatment of an ica-cs that was not ruptured.The max diameter was about 15mm with a neck width of 5mm.The distal landing zone was 3.4mm and the proximal was 4.5mm.The anatomy was moderate in tortuosity.There was no patient injury.There are no images.The devices were prepared and used per the instructions for use (ifu).

Manufacturer Narrative

The pipeline flex with shield pusher was returned without the braid or the catheter.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The outer diameter (o.D) of the re-sheathing pad was measured and found to be within specifications.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pipeline flex pusher appeared to be have separated at the distal hypotube.Kinks and bends were found on the pusher at near the proximal end.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.No other anomalies were observed.The broken end of the pusher was sent out for scanning electron microscopy (sem) analysis.Based on the analysis findings, the pipeline flex was confirmed to have pushwire separation, as the pipeline flex pusher was found to be separated at the distal hypotube.The fracture surface features of the broken end are consistent with tensile overload.From the damages seen on the pipeline flex pusher (kinking/bending) and hypotube (stretching and separating); it appears there was high force used.It is likely these damages occurred when attempted to retrieve the pipeline flex pusher through the catheter against resistance.Since the catheter was not returned; any contribution of the catheter to the issues could not be determined.It is likely that the patient tortuous anatomy may contributed to the resistance during retrieval; subsequently causing the pusher to become stuck and separated.Based on the returned devices, there was no device malfunction or no non-conformance to specifications identified that led to the reported issues.In addition, the review of lot history records shows that the finished pipeline flex has met all manufacturing requirements and specifications during final assembly and quality inspection.Per our instructions for use (ifu): ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an "intraluminal" device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.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.¿ all devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.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.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: 8893315
• MDR Text Key: 154412799
• Report Number: 2029214-2019-00842
• 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: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-350-30
• Device Lot Number: A821016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR