MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; LASER THERAPY PRODUCT

Model Number PED-250-16

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

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

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has not been returned for evaluation; therefore, product analysis cannot be performed.The device was not returned; therefore, the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that during retrieving from the patient the pushwire broken at the marked point.The patient was undergoing embolization treatment for a small unruptured saccular aneurysm located in middle cerebral artery m1 segment, measuring 3.2mmx3.5mm, landing zone distal 2.5mm, proximal 2.7mm.The vessel was normal tortuous.It was reported that after the successful deployment of the ped implant, when the surgeon retrieved the delivery guidewire, the protective sheath failed to be successfully retrieved into the microcatheter.The delivery pushwire and the microcatheter were completely withdrawn from the body, and during the withdrawal process, the proximal end of the delivery pushwire was broken at the marked point.There were not any patient symptoms or complications associated with this event.Yes, dual antiplatelet therapy administered.The angiographic result post procedure shows slow blood flow.No patient injury was reported.The pipeline and any accessory devices were prepared as indicated in the ifu.

Manufacturer Narrative

No flash or voids molded were observed in the phenom-027 hub.The pipeline flex pusher was found extending out of the hub ~32.5cm.The pipeline flex pusher was retracted out of the phenom-027 with no resistance.The catheter total length was measured to be ~158.9cm, the usable length was measured to be ~152.4cm and the distal single coil length was measured to be 14.6cm which is within specification per drawing.Total length (reference) = 156.5cm, usable length = 150cm ± 5cm; distal single coil length = 15cm ±2cm).No damages or irregularities were found with the catheter body, distal tip or marker band.The inner diameter of the phenom-027 was measured via pin gauge to be 0.0270¿ (proximal) and 0.0270¿ (distal) which is within specification: 0.027¿ ± 0.001¿ and compatible for use with the pipeline flex device.An in-house 0.026¿ mandrel was then used for resistance testing.The mandrel was inserted through the catheter hub, through the catheter body and exited the catheter tip with no issues and no resistance encountered.The pusher hypotube was found broken near the distal end of the hypotube with the ptfe shrink tubing damaged at that same location.No stretching was found with the hypotube.The distal broken segment was not returned for analysis.The broken end of the hypotube was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.Sem/eds summary: ¿the fracture surfaces exhibit significant corrosion damage that obscured the origin fracture features.¿ no other anomalies were found.Based on the analysis findings, the customer report of ¿catheter resistance¿ and ¿resistance during re-sheathing/failure to resheath¿ could not be confirmed as no resistance was found with the catheter during mandrel testing.As the distal broken segment of the pusher was not returned for analysis, any contribution of the distal pusher towards the resistance could not be determined.The customer report of pushwire break was confirmed.It is possible the customer used high force when retracting the pusher causing the hypotube to break.Customer reported resistance within retracting the pipeline flex pusher.The sem testing did not confirm an overload type failure due to corrosion.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 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.¿ possible contributors towards failure are patient vessel tortuosity, catheter damage or user re-sheaths more than two times.Customer reported patient vessel tortuosity as normal.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: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10209593
• MDR Text Key: 198500947
• Report Number: 2029214-2020-00624
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536014435
• UDI-Public: 00847536014435
• 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: 09/24/2020

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: 09/27/2022
• Device Model Number: PED-250-16
• Device Catalogue Number: PED-250-16
• Device Lot Number: A906062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR