MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; LASER THERAPY PRODUCT

Model Number PED2-400-16

Device Problems Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problem Stenosis (2263)

Event Date 10/01/2020

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 there was resistance between the pipeline and phenom during deployment, and the guide separated from the pipeline.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left carotid siphon with a max diameter of 4 mm and a 3.5 mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was a dministered: prasugrel.It was reported that the phenom microcatheter was placed in the m1 segment, and then placed in the desired distal landing zone of a healthy carrier vessel.The deployment of the pipeline met difficulty where the first segment was able to appositioned, but then the delivery force began to increase in the distal segment of the catheter.A closed stenosis appeared, and the recommended maneuvers to stabilize the deployment and releasing the slack were performed but not successful.At that moment, the guide was separated from the pipeline device, and an entrapment of the prosthesis was generated within the microcatheter with impossibility of moving it.The operator said this was a rare situation as it had not happened before, and then the entire system was removed.It was found the catheter was crushed, and there was no damage to the pushwire.Another pipeline was then used with a marksman microcatheter, and the procedure was completed without any reported issues.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiography sowed exclusion of the aneurysm.Ancillary devices include a phenom 27 microcatheter.

Event Description

No additional information received.

Manufacturer Narrative

H6: method code updated to b01.Result code updated to c19.Conclusion code updated to d15.H10: it was previously reported the event no longer met the reporting requirements stipulated in 21 cfr 803.This was reported in error.While the analysis results refute the pushwire separation/break, the analysis results could not refute or determine a root cause for the pipeline failure to open.This event is still reportable per 21 cfr 803.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 that the distal portion was open and the middle segment that could not be opened was located in the carotid siphon.

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.

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 clarified that after the first segment of the pipeline was deployed, the physician had difficulty continuing to open it.The physician performed maneuvers to deploy it, and at that moment they noticed that the pipeline separated of the guide and part of the pipeline was trapped inside the phenom.The doctor stated the pipeline was "glued" inside phenom without the possibility of moving the pusher.The entire system was removed and another microcatheter and pipeline were used.

Manufacturer Narrative

Analysis of the pipeline flex shield pushwire (model: ped2-400-16 lot: a874053) and phenom 27 catheter (model: fg15150-0615-1s lot: ap19-045) found that the pipeline flex shield braid was not returned.When compared to the drawings: the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No bend was observed on the pushwire.No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The catheter tip, marker band and body were examined; and no damages were found.No flash or voids molded were observed in the hub.The catheter was flushed with water without any issues.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip with no issues.Based on the analysis findings, the pipeline flex shield was not confirmed to have resistance during delivery, failure to open proximal and pushwire break/separation.In addition, the phenom 27 catheter could not be confirmed to have resistance during delivery, and catheter crushed.The root cause could not be determined as no damages were found with the returned pipeline flex shield pushwire and catheter.Since the pipeline flex shield braid was not returned, any contribution of the braid to the reported issues could not be determined.Possible causes include patient tortuous anatomy and lack of continuous flush during delivery.Review of analysis results shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned in a way that may have led to a death or serious injury.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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

No additional information received.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10640184
• MDR Text Key: 210180915
• Report Number: 2029214-2020-01005
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2022
• Device Model Number: PED2-400-16
• Device Catalogue Number: PED2-400-16
• Device Lot Number: A874053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/07/2020; 10/20/2020; 12/07/2020; 12/07/2020
• Supplement Dates FDA Received: 10/20/2020; 10/28/2020; 12/21/2020; 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 70