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

Model Number PED2-325-12

Device Problems Positioning Failure (1158); Component or Accessory Incompatibility (2897); Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problem Bradycardia (1751)

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline failed to open.The patient was undergoing treatment for a ruptured, amorphous aneurysm located in the right ica.The max diameter and neck diameter were 6mm.The patient's vessel tortuosity was moderate.The landing zone was 2.9mm distal and 3.0mm proximal. dual antiplatelet treatment was administered, and the radiologist was satisfied with the pru levels.It was reported that the procedure was initially an acute case, but the radiologist wanted to try to place a coil.Therefore, a sheath and navien were placed, 3d performed and a phenom 27 microcatheter was taken into the m2/3 branch.The echelon microcatheter was placed into the aneurysm.There was difficulty navigating past the aneurysm and wires kept popping into the lesion, but this did not cause any issues.The pipeline was initially opened in the m1 region.The stent opened slightly distally but not fully, likely restricted by the size of vessel and position.The pipeline was drawn back into terminal ica and looked to be opened slightly better.However, it was difficult to visualize and appeared not to be opening well in mid section.The patient then experienced a short bradycardia event, but anesthetist checked patient and this resolved quickly after a minute.A further attempt was made to open; however, the radiologist was unhappy with how it performed.Resheathing was attempted; however, the system was on a bend and they felt the device was on an angle and it would not resheath smoothly.They decided something was not right with device and removed it.They were able to resheath with one gently further attempt.It was decided to remove the echelon catheter and abandon the coiling element as it was thought to be likely not required and was potentially adding additional difficulty and hindering deployment of stent.A phenom 21 system was placed with a new pipeline.They opened it in the m2/1 initially and dragged it back to the proximal m1 with the intention to drop it there and into the ica, avoiding perforators.The device opened well distally and throughout to good result. it was noted that there was a stenotic segment at the distal ica.The radiologist had advised that dropping at the terminal ica stent may potentially slip back due to vessel shape, so a second stent was deployed in m1.The patient did not experience any injury.Angiographic results post procedure were said to be good.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a neuron max sheath, navien 72 guide catheter, echelon 10 microcatheter, phenom 27 microcatheter, traxcess 14 guidewire, and synchro 14 guidewire.

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 reported the pipeline had fish-mouthed appearance.It was unknown if the pipeline jumped or if the catheter was moved during deployment.No other devices or maneuvers were attempted to open the pipeline.

Manufacturer Narrative

H3: the pipeline flex w/ shield device and phenom-27 micro catheter were returned for analysis.No damages or irregularities were found with the phenom-27 catheter hub.Dried saline was found within the hub.The pipeline flex w/ shield pusher was found extending out the hub ~42.6cm.No damages or irregularities were found with the micro catheter body or marker band.The distal tip was found damaged.The pipeline flex w/ shield tip coil was found extending out of the distal tip.The hypotube was found unstretched and undamaged with the ptfe shrink tubing still intact.No damages were found with the distal marker, re-sheathing marker, resheathing pad or with the proximal bumper.The distal and proximal dps restraints were found to be intact.The dps sleeves were found bunched up.The tip coil was found intact and unstretched.Once fully deployed out of the micro catheter, the entire length of the pipeline flex w/ shield braid was found fully opened.The distal braid end was found damaged and frayed and the proximal braid was found slightly frayed.The phenom-27 micro catheter total length was measured to be ~158.6 and the usable length was measured to be ~152.1cm, which is within specification (specification: total (ref) = 156.5cm, usable = 150cm ± 5cm).The pipeline flex device could not be retracted back within the phenom-27 micro catheter as it was stuck at the distal catheter due to the bunched up dps sleeves.The device was advanced out with no resistance encountered.Based on the analysis findings, the customer report of ¿failure/incomplete open at middle section (hourglass shape)¿ could not be confirmed.Possible causes for incomplete open during the procedure are patient vessel tortuosity, damaged braid, braid improperly size to anatomy, braid overstretched during delivery, user deploys braid in vessel bend, presence of other indwelling endovascular stents or inappropriate anatomy.The customer report of ¿difficult placement/positioning¿ could not be confirmed through device analysis.Possible causes are patient vessel tortuosity, braid incorrectly sized to vessel, resistance, other indwelling endovascular stents, braid damaged, braid deployed in vessel bend, micro catheter tip not correctly placed, or braid not anchored correctly.Customer report of ¿poor device visualization¿ could not be confirmed through device analysis.Possible causes of failure are imaging equipment, material in the path, patient placement, or position of braid.The customer report of ¿resistance during resheathing¿ and ¿catheter resistance¿ was confirmed.The cause of the resistance was found to be the dps sleeves got bunched up and prevented the tip coil from retracting into the micro catheter tip and caused the micro catheter tip to become damaged.Customer reported all devices were prepared per ifu, patient vessel tortuosity as moderate, and device was positioned in a bend.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: 12991871
• MDR Text Key: 283689141
• Report Number: 2029214-2021-01603
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2023
• Device Model Number: PED2-325-12
• Device Catalogue Number: PED2-325-12
• Device Lot Number: B011805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2020
• 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
• Patient Sex: Female