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

Model Number PED-400-18

Device Problems Break (1069); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

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

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report of pipeline flex pushwire break during a procedure.The patient was undergoing embolization treatment for a flow diversion of a small unruptured saccular aneurysm located right internal carotid artery (ica) in c4-c5 segment.Measuring 5.5mm4mm.Landing zone distal 3.6mm proximal 4.18mm.The vessel was observed severely tortuous.The devices were prepared as indicated in the ifu.A continuous flush was maintained during the procedure.It was reported that during the intervention, the pipeline flex was delivered to the distal section of the catheter.The pipeline flex was not able to be pushed from the catheter despite applying force.The catheter and pipeline flex were removed as a unit from the patient.After removal, the pipeline flex tip coil was observed to be broken.There were no reports of patient injury in association with this event.

Manufacturer Narrative

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

Additional information received noted the second set of devices would not be returned as it deployed completely.A segment was left in the c6 of the patient.The 1st pipeline tip coil broke and was found in the first marksman catheter after it was removed from the patient.

Manufacturer Narrative

The pipeline flex stuck within the microcatheter.For further examination, the pipeline flex was then pushed out from the catheter l umen with difficulty.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The pusher appeared to be broken proximal to proximal the dps restraint.The outer diameter (o.D) of the re-sheathing pad was measured within specifications.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 braid fully opened and moderately frayed.Kinks and bends were found on the pusher.No damages were found with the re-sheathing marker or with the proximal bumper.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.The broken segment was then sent out for scanning electron microscopy (sem) analysis.No other anomalies were observed.Based on the analysis findings and sem, the pipeline flex and catheter were confirmed to have pushwire separation and resistance during delivery.The returned pipeline flex was stuck inside the catheter.In addition, the pipeline flex pushwire failed via torsional overload.Additionally, the pipeline flex and catheter were found to be damaged.From the damages seen on the catheter body (stretching and accordinoning), distal pushwire (broken), proximal pushwire (kinking/bending), pipeline flex braid (fraying) and hypotube ( stretching); it appears there was high force used.It is likely these damages occurred when the attempted to advance and retrieve the pipeline flex through the catheter against resistance.It is likely that the severe vessel tortuosity may have contributed to the reported issues.There was no non-conformance to specification identified that led to the resistance during delivery.Per our instructions for use (ifu), the user should: ¿discontinue delivery of the device if high force or excessive friction is enco untered 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 intralumenal device against resi stance 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.

• 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: 8862647
• MDR Text Key: 179104532
• Report Number: 2029214-2019-00814
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00836462015418
• UDI-Public: 00836462015418
• 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,Followup
• Report Date: 09/30/2019

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 Model Number: PED-400-18
• Device Catalogue Number: PED-400-18
• Device Lot Number: A729553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 08/11/2019; 09/19/2019
• Supplement Dates FDA Received: 08/23/2019; 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR