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

Model Number PED3-027-400-14

Device Problems Positioning Failure (1158); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 02/07/2023

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.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

Medtronic received information that a ped3 pipeline vantage failed to open in the proximal section.The physician couldn¿t recapture the partially opened stent due to the impossibility to manage stent push wire and microcatheter for an instability of the system.To avoid the probability that the stent falls into the aneurysm treated , the physician decided to remove the stent and try to open in air it with success.Physician opened the flow diverter after removal from patient and accidentally the push wire of the stent went down on the floor without reaching about it.The pipeline was not positioned in a bend.It was not stuck in the capture coil.Less than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed less than or equal to 2 tiems.No additional steps were taken to open the pipeline.The pipeline was resheathed and removed from the patient with the microcatheter.There was catheter resistance in the distal section.The devices were prepared as indicated in the instructions for use (ifu) and the catheter was flushed as per ifu.Second flow diverter implanted correctly and there was flow diversion.The patient was being treated for an unruptured, saccualr aneurysm in the internal carotid artery (ica).The max diameter was 3.8mm and the neck diameter was 3mm.The distal landing zone was 3.5mm and the proximal landing zone was 4mm.Vessel torutoisty was normal.Dual antiplatet treatment was administered.The access vessel was the femoral with a diameter of 8mm.No patient symptoms or complications were reported.

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 no friction during delivery, just in positioning due to the absence of stability.T the device jumped during deployment and there was no moving of tip catheter.

Manufacturer Narrative

H3.Product analysis: equipment used: video inspection system (m-81805), ruler (m-83360), pin gauge sets (m-84082, m-84081), camera (panasonic lumix dmc-zs5) as found condition: the pipeline vantage device was returned for analysis within a shipping box; within two sealed tyvek biohazard p ouches and without its introducer sheath.The already detached braid was returned further within a plastic vial.The phenom-27 micro catheter used during the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the proximal pusher.The hypotube was found intact and unstretched and ptfe shrink tubing was still intact.No damages were found with the proximal bumper, spacers, supporting disks or advance resheathing mechanism.The distal and proximal dps restraints and dps sleeves were found intact with no signs of damage.No damages or irregularities were found with the tip coil.The entire braid length was found fully opened.One braid end was found slightly frayed.The other braid end was found damaged and frayed.Testing/analysis: the pipeline vantage device could not be used for resistance testing as the braid was already deployed.Conclusion: based on the analysis findings, the customer report of ¿failure/incomplete open proximal (flex)¿ could not be confirmed as both braid ends were found fully opened.The root cause could not be determined.Possible causes for failure to open during the procedure include patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, or inappropriate anatomy.The braid was found damaged.Potential causes for braid damage are, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, or deploying/resheathing braid against resistance.Customer reported pipeline was not positioned in a bend, pipeline was resheathed less than or equal to 2 times, devices were prepared per ifu, and vessel tortuosity as normal.The customer report of ¿difficult placement/positioning¿ could not typically be confirmed through device analysis.Possible causes for difficult positioning are patient vessel tortuosity, braid incorrectly sized to vessel, resistance, braid damaged, micro catheter tip not correctly placed, or braid not anchored correctly.The customer report of ¿resistance during resheathing/failure to resheath¿ could not be confirmed.Possible causes are patient vessel tortuosity, resistance during delivery/retrieval of device (causing damage), catheter damage, or user does not maintain continuous flush.As the phenom-27 micro catheter and the introducer sheath used during the event was not returned for analysis, any contribution of the phenom-27 and the introducer sheath towards the failures could not be determined, and any non-conformances to specifications could not be assessed.H6.Coding updated based on analysis results.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 VANTAGE WITH 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: 16375506
• MDR Text Key: 309969000
• Report Number: 2029214-2023-00281
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED3-027-400-14
• Device Catalogue Number: PED3-027-400-14
• Device Lot Number: B350391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2022
• 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
• Patient Sex: Female