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

Model Number PED-400-30

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

Non-complaint.Non-complaint.Non-complaint the pushwire appeared to be separated at the distal hypotube.The distal segment of the pusher was stuck inside the catheter.For further examination, the catheter was cut to remove the distal segment and braid from the catheter lumen.When compared to the drawings the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The hypotube was found to be stretched.No damages were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No bend or kink were observed on the pushwire.The distal and proximal end of the pipeline flex braid were found fully opened and moderately frayed.The total and usable lengths of the catheter were measured to be within specification.No flash or voids molded were observed in the hub.The catheter body was found to be accordion from ~28.5cm to ~32.0cm from distal tip.In addition, the catheter body was appeared to be flattened from ~1.5 cm to ~7.5 from distal tip.The catheter distal tip and marker band were found to be flattened.The catheter was flushed with water and water exited out of the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip with no issues; however, the resistance observed at the damaged locations.No other anomalies were observed.Based on the analysis findings, the pipeline flex and marksman catheter were confirmed to have resistance during delivery and damaged.The pushwire and catheter were found to be damaged.From the damages seen on the catheter body (accordioning/flattening), pusher (separating), pipeline flex (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance/retrieve the pipeline flex through the catheter against resistance.It is likely that the moderate vessel tortuosity may have contributed to the reported issues.Addition ally, the pushwire was found to be separated at the distal hypotube.Per the sem result the fracture surface exhibits dimple features indicative of bending/twisting type overload failure mechanism.It should be noticed that surface indications are visible on the fracture surface, indicating pre-existing defects that could contribute to the failure observed.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the delivery of the pipeline in the microcatheter, when passing through the bifurcation of the internal carotid artery, the pipeline was stuck at the distal end of the microcatheter and could not be pushed forward or retrieved.Therefore, the pipeline and microcatheter were withdrawn from the body as a whole, and the distal end of the microcatheter was found to be accordion-like damage.It was noted the catheter was flushed as indicated in the ifu.The patient was undergoing surgery to treat an unruptured, amorphous aneurysm with a max diameter of 18.86mm and a neck diameter of 16.43mm.The distal landing zone was 3.17mm, and the proximal landing zone was 3.65mm.The access vessel was the femoral artery, and the access vessel diameter was 7.9mm.It was noted the vessel tortuosity was moderate.Dapt (dual antiplatelet treatment) was administered.The pru level was 0.The angiographic result post procedure was partial residue.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.

Manufacturer Narrative

H6.Conclusion code corrected based on conclusions from analysis.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: 10913911
• MDR Text Key: 218522256
• Report Number: 2029214-2020-01197
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015999
• UDI-Public: 00847536015999
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2023
• Device Model Number: PED-400-30
• Device Catalogue Number: PED-400-30
• Device Lot Number: B013777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR