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

Model Number PED3-021-300-20

Device Problem Activation Failure (3270)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

This is a report for a similar device that is not marketed in the us.Suspect medical device - similar device brand name = pipeline vantage with shield technolog: model # = ped3-021-300-20.The pipeline vantage with shield technology embolization device braid was implanted in the patient.However, the pushwire is expected to be return.Upon receipt of the device, a supplemental report will be filed.Mdrs related to this event: 2029214-2020-00666, 2029214-2020-00667.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that two pipeline vantage with shield technology embolization devices did not open during the procedure.It was reported that two pipelines were intended to be placed, one in left a2-left a1 and one in right a2 to right a1 and coil the anterior communicating artery.Medtronic distal access support catheter was loaded with the medtronic 21 and medtronic 17 catheters.Echelon 10 catheter jailed in the aneurysm, while ped3-300-20 was deployed.The distal end opened beautifully, but 'kinked' when it crossed the area that the echelon 10 seemed to enter the aneurysm.Continued deployment, and tried to detach, but the pipeline was stuck on the detachment mechanism.This means that the proximal end of the device would not open and was not released from the detachment mechanism.When the delivery wires were pulled proximally the device moved with it (indicating it was still attached).The physician did not want to get it detach it until the coils were in the aneurysm, and the pipeline would be protected from slipping distal.It was reported that the second pipeline vantage with shield technology embolization device on left side was deployed through another medtronic 21 catheter, which ran through a non-medtronic guidecatheter.This deployment also went well, but the proximal end of the pipeline seemed to get stuck on the detachment mechanism as well.A 'jiggle' seemed to free it, but it was definitely noted.(this means, the device did not release immediately when the catheter was very obviously proximal to the detachment marker.The catheter and wires were pulled back and forth in order to free the device).The coils deployed through echelon 10 and filled the sac nicely.Once coils in place, coiling catheter was removed and physician worked on the first reported ped3-021-300-20 to free it.Pulled it into inner curvature and loaded it.Microcatheter was close to provide support.The physician was unsure what exact move freed it, but it did become detached.The physician tried to use wires and catheters to work out the kink, but it did not work.Used the non-medtronic balloon and opened up the kink (and worked on better apposition distal to the aneurysm.The patient was undergoing treatment for an unruptured, amorphous aneurysm located in the anterior communicating artery.The max diameter was 9 mm.The neck diameter was 4 mm.The vessel tortuosity was severe.There were no reports of patient injury in association with this event.

Manufacturer Narrative

D4: expiration date - additional information.H4: device mfg date -additional information 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.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

The pipeline vantage pusher (model: ped3-021-300-20 lot: a957302) was returned for returned for analysis.No damages or irregularities were found with the pipeline vantage pusher or introducer sheath.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 intact and unstretched and ptfe shrink tubing was still intact.No damages were found with the spacers, tip coil, advanced re-sheathing mechanism or spacers.No other anomalies were observed.Based on the analysis findings, the customer report of ¿failure/incomplete to open at middle section (hourglass shape)¿ could not be confirmed as the pusher was returned without the braid.Possible causes for failure are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid overstretched during deliver, user deploys braid in vessel bend, presence of other indwelling endovascular stent and inappropriate anatomy.Customer reported patient vessel tortuosity as severe and that the kinked area was situated over an echelon-10 catheter within the aneurism.As the braid and phenom-21 micro catheters used during the event were not returned for analysis, any contribution of the braid and phenom-21 micro catheters towards the incomplete open could not be confirmed.The inner diameter of the phenom-21 is.021¿, which is compatible for use with the pipeline vantage.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 EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10243201
• MDR Text Key: 199830974
• Report Number: 2029214-2020-00666
• Device Sequence Number: 1
• Product Code: OUT
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2023
• Device Model Number: PED3-021-300-20
• Device Catalogue Number: PED3-021-300-20
• Device Lot Number: A957302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR