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

Model Number PED2-450-20

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 01/20/2023

Event Type  malfunction  

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.

Event Description

Medtronic received a report that the pipeline pushwire broke and was unable to be resheathed.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right ica.The max diameter was 7mm, and the neck diameter was 4mm.The patient's vessel tortuosity was moderate.The landing zone was 3.8mm distal and 4.2mm proximal.The access vessel was the ica, which was 4mm in diameter.It was reported that after flushing both the microcatheter and pipeline and then delivering guidewire to the approach site first, the guidewire was replaced with the pipeline.At this point, it felt "heavier" than in past cases, but the doctor proceeded with the deployment operation.The sleeve was removed, but again, the doctor felt "heaviness" and was unable to resheath it.The proctor, a physician from okayama university, suggested that there might be something wrong with the device, so the entire system was removed from the body.After checking outside the body, it was determined that 1.5 cm wire at the tip of the delivery wire was inserted into the stent, and that the proximal end of the stent should have been stopped by the silicone bumper, but it was dislodged and so it was replaced. after that, another microcatheter and flow diverter were taken out, which were deployed smoothly and without any resistance during delivery.The procedure was completed. the patient did not experience any health damage.Angiographic results post procedure showed no particular problems.The devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include a phenom 27 microcatheter.

Event Description

New information was received.The physician always felt heavy and hard when delivering.The hardness is only felt from the wires on hand.It is unknown if there was any damage to the catheter observed.

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 was received that the internal carotid artery position was c3-c4.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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.

Manufacturer Narrative

H3: product analysis of ped2-450-20, lot# b361805 visual inspection/damage location details: the pipeline flex w/ shield distal braid and tip coil was found already deployed out of the catheter tip.The hypotube was found unstretched and undamaged with the ptfe shrink tubing still intact.The resheathing pad and resheathing marker were found loose on the distal delivery wire.No damages or irregularities were found with the proximal bumper.The distal and proximal dps restraints were found to be intact.The ptfe dps sleeves were found damaged and bunched up.The tip coil was found intact.Both braid ends were found fully opened, damaged, and frayed.The middle braid was found damaged.Testing/analysis: the pipeline flex w/ shield device could not be retracted back within the micro catheter as it became stuck at the damaged dps sleeves and was advanced out with no resistance encountered.The inner diameter of the micro catheter was measured to be 0.0265¿ at the proximal end and 0.0275¿ at the distal end, which is within specification (specification: 0.027¿ ± 0.001¿).An in-house 0.0265¿ mandrel was inserted into the hub, through the micro catheter body and out the distal end with no resistance encountered.Conclusion: based on the analysis findings, the customer report of ¿resistance during re-sheathing/failure to re-sheath¿ was confirmed; however, the report of ¿resistance/stuck during delivery¿ could not be confirmed.The cause of the resistance was found to be the damaged dps sleeves.The cause of the sleeve damage could not be determined.No damages or irregularities were found with the returned pusher or micro catheter that would contribute towards the resistance.In addition, no resistance was found with the returned micro catheter during in-house mandrel testing.Possible contributors towards resistance are damage/fraying of the braid, patient vessel tortuosity, insufficient continuous flush or user pulls back on/torques wire while advancing ped in micro catheter.The braid was found damaged.Potential causes for braid damage are high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, deploying/re-sheathing braid against resistance or damage during return shipping to medtronic as the distal and middle braid were returned deployed unprotected out of the micro catheter tip.The customer report of ¿pushwire break/separation¿ could not be confirmed as the pushwire was found unbroken, however, the resheathing pad and distal pad restraint were found loose on the distal delivery wire.It is likely the pad/restraint became lose due to advancing/retracting the device against the reported resistance.The pipeline flex w/ shield device is compatible for use with the phenom-27 micro catheter.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 W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 16225145
• MDR Text Key: 309087072
• Report Number: 2029214-2023-00104
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-450-20
• Device Catalogue Number: PED2-450-20
• Device Lot Number: B361805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1