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

Model Number PED2-300-14

Device Problem Break (1069)

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

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not be 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 received information that during use of the second pipeline flex with shield, the adjunctive coiling catheter come out of the aneurysm and it could be repositioned into the aneurysm.However, it again prolapsed into the parent vessel along with the first coil.An attempt was made to recapture the pipeline, but the wire separated from the device.The pipeline separated from the resheathing pad.All devices were removed from the patient.No device was reported to have been implanted in the patient.The procedure was not completed, and the patient was scheduled for retreated on (b)(6) 2019.The patient was undergoing embolization treatment of a ruptured blister aneurysm (unknown dimensions) located in the right internal carotid artery (ica) above the pca.The distal and proximal landing zones were unknown.The patient¿s vasculature was normal in tortuosity.

Manufacturer Narrative

The pipeline flex with shield stuck at the distal segment of the catheter were returned.For further examination, the pipeline flex with shield was pushed out from the catheter lumen with difficulty.The pushwire appeared to be intact.No separation was observed on the returned pusher.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 within specifications.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the pipeline flex with shield braid fully opened and moderately frayed.Bend was found on the pusher near the proximal end.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.Based on the analysis findings, the pipeline flex with shield was not confirmed to have pushwire separation; as the returned pipeline flex with shield delivery system was intact.No separation was found.The returned pipeline flex with shield was stuck inside the distal segment of the catheter.The pipeline flex with shield was damaged.From the damages seen on the pipeline flex shield braid (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex with shield.It is possible that the lack of continuous flushed with heparinized saline during procedure may have contributed to the resistance during delivery.Per our instructions for use (ifu): ¿place the micro catheter tip at least 20 mm past the distal edge of the aneurysm.Gently retract the micro catheter to reduce slack in the micro catheter prior to inserting pipeline¿ flex embolization device.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 intralumenal 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.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.

Event Description

Medtronic received information that the delivery system of the 1st pipeline jammed as the physician was trying to recapture it.It could not be recaptured during the second resheathing attempted and the pipeline was stuck in the middle of the microcatheter.The 2nd pipeline, the adjunctive coiling catheter come out of the aneurysm and it could be repositioned into the aneurysm.However, it again prolapsed into the parent vessel along with the first coil.An attempt was made to recapture the pipeline, but the wire separated from the device.The pipeline separated from the resheathing pad.The 2nd pipeline was removed via delivery catheter and micro catheter.All devices were removed from the patient.No device was reported to have been implanted in the patient.The procedure was not completed, and the patient was scheduled for retreated on 21-feb-2019.The patient was retreated with pipeline device.The patient was undergoing embolization treatment of a ruptured blister right ica suprachlionoid aneurysm (unknown dimensions) located in the right internal carotid artery (ica) above the pca.The distal and proximal landing zones were unknown.The patient¿s vasculature was normal in tortuosity.There was no damage to the catheter or pushwire for the first pipeline.The patient is doing satisfactory.Stryker coils were used.Phenom 27 for ped2 deployment, sl10 for coils and echelon 10.No catheters models lot numbers available as these are not recorded by the unit.No further information will be available.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8412960
• MDR Text Key: 138565814
• Report Number: 2029214-2019-00192
• 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: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2020
• Device Model Number: PED2-300-14
• Device Catalogue Number: PED2-300-14
• Device Lot Number: A502829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR