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

Model Number PED3-027-400-12

Device Problems Difficult or Delayed Positioning (1157); Positioning Failure (1158); Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a pipeline vantage that had issues with positioning and opening at the proximal end.The patient was undergoing a procedure for flow diverter implantation to treat a previously coiled saccular aneurysm of the right internal carotid artery (ica) posterior communicating (pcomm) segment.The aneurysm max diameter was 5mm and the neck diameter was 5mm.Vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was administered.It was reported that the pipeline vantage stent was placed at the top end of the ica terminus.The phenom microcatheter was brought past the m1 aneurysm.The pipeline was advanced and unsheathed to place the tip coil past the m1 aneurysm.The stent was brought back to the proximal end of the m1 and deployment began.The stent opened but was observed to be too distal to the terminus after 90% was deployed so the pipeline was resheathed and repositioned more proximal.This was repeated 5 times.The stent was then in a correct position and deployed.The proximal end was enclosed on itself.The surgeon attempted to push the microcatheter through the stent to open it but the stent closed more instead.Many attempts were made but the stent remained closed.Finally a non-medtronic microcatheter was used with a non-medtronic guidewire as a "buddy wire" to get into the stent and both wires together to open the proximal end of the pipeline vantage stent.The non-medtronic microcatheter was placed through the stent and exchanged with a phenom 27 microcatheter.An additional pipeline was then also implanted.It was noted that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu).There were no patient symptoms or complications associated with this event.Post-procedure angiography showed good results.

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 indicated there was no issue with the phenom microcatheter.The proximal end of the pipeline was deployed in a straight segment of the vessel with minimal bend.The middle section had bend with the neck of the aneurysm.

Event Description

Additional information received reported corelab reported "occlusion of pcom" at the 180-day follow up dsa imaging on 17-jan-2022.No impact to patient was 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.

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 that the site has confirmed that multiple pipelines implanted was not due to a dd.Furthermore, site has denied corelab finding of "pcom occlusion" with response "answer 19/05/2022 as per assoc pi ld hemodynamic changes with no antigrade flow in pcom not ae reportable.".

Event Description

Additional information received reported the second pipeline was implanted for full aneurysm neck coverage due to insufficient proximal coverage with the first pipeline which shortened more than anticipated.

Manufacturer Narrative

B5.Updated with additional information received.H6.Coding updated based on additional information received.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 was received that per corelab image read on 6m dsa on (b)(6) 2022 and read on (b)(6) 2021 treatment dsa noted pipeline braid hump deformation.The site reported no symptoms or actions taken in association with this finding.

• 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: 12189634
• MDR Text Key: 262263594
• Report Number: 2029214-2021-00877
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2024
• Device Model Number: PED3-027-400-12
• Device Catalogue Number: PED3-027-400-12
• Device Lot Number: B159989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Date Device Manufactured: 02/11/2021
• 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 Age: 54 YR
• Patient Sex: Female