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

Model Number PED-450-25

Device Problem Break (1069)

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

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex braid will not be returned as it remains in the patient; however, the pushwire is expected to be return.Upon receipt of the device, a supplemental report will be filed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report of pipeline flex device pushwire broke during the procedure.The patient underwent embolization treatment of flow diversion for a medium size aneurysm.It was reported that pipeline device felt resistance in the medtronic microcatheter during deployment and pushwire broke.The pipeline was implanted in the intended location.The separated pushwire was removed with the aid of a snare device.The vessel was observed moderately tortuous.There were no reports of patient injury in association with this event.

Manufacturer Narrative

The pipeline flex delivery system and catheter were returned for evaluation without the pipeline flex braid as it was implanted in the patient.The distal and proximal dps restraints were found intact.The dps sleeves were found intact with no signs of damage.The outer diameter (o.D) of the re-sheathing pad was measured to be within specifications.The distal hypotube was found to be stretched with the ptfe shrink tubing still intact.The pipeline flex pushwire appeared to be detached at the hypotube proximal to the wire weld.Kinks and bends were found on the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.No other anomalies were observed.The surfaces of the detached pushwire were then sent out for scanning electron micrographic (sem) and energy dispersive spectroscopy (eds) analyses.Based on the analysis findings and the sem/eds analyses, the customer's reports of ¿pushwire separation¿ was confirmed.The pipeline flex pushwire was found to be to be detached at the hypotube proximal to the wire weld.The pusher and catheter were damaged at several locations.From the damages seen on the catheter body (stretching/accordioning), distal wire (detaching), proximal wire (kinking/bending), and hypotube (stretching); it appears there was high forced used (pushing and pulling).It is likely these damages occurred when it was attempted to advance/retrieve the pipeline flex through the catheter against resistance.The distal wire of the pipeline flex delivery system was possibly detached due to tensile failure.It is likely that the patient tortuous anatomy may have contributed to the reported issues.A review of the manufacturing process did not uncover any deficiencies regarding the soldering process.Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures.In addition, the elemental analysis conducted through scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) showed presence of soldering material (tin); thereby indicating that the soldering was conducted.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).There was no non- conformance to specification that lead to the resistance and detachment issues.Furthermore, 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): "discontinue delivery of the device if high force or excessive friction is encountered.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.¿ 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
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8588596
• MDR Text Key: 144400608
• Report Number: 2029214-2019-00432
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: PED-450-25
• Device Catalogue Number: PED-450-25
• Device Lot Number: A468652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention