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

Model Number PED-450-25

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Stenosis (2263)

Event Date 11/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received information reporting that a patient underwent a procedure for pipeline flow diversion implantation to treat an aneurysm.There were no device or procedure issues noted.At 180-day follow-up on (b)(6) 2019, imaging showed residual aneurysm (raymond roy class 3).No action was taken at that time. 1 year follow up imaging performed on (b)(6) 2020 showed residual neck (raymond roy class 2) and parent artery stenosis >25-50%.Aspirin was continued an no other further action was taken at that time.Additional follow up  for digital subtraction angiography (dsa) imaging performed on (b)(6) 2020 showed residual aneurysm neck (raymond roy class 2) and parent artery stenosis >50-75%; the patient also experiencing associate symptoms.The patient underwent a retreatment procedure on (b)(6) 2021 in which an additional non-medtronic flow diversion stent was implanted to address the residual aneurysm/residual aneurysm neck.

Event Description

Additional information received clarified that the 1 year follow-up imaging was performed on (b)(6) 2020 and showed parent artery stenosis >25-50%.

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 reporting that a patient underwent a procedure for pipeline flow diversion implantation to treat an aneurysm.There were no device or procedure issues noted.At 180-day follow-up on (b)(6) 2019, imaging showed residual aneurysm (raymond roy class 3).No action was taken at that time. 1 year follow up imaging performed on (b)(6) 2019 showed residual neck (raymond roy class 2) and parent artery stenosis >25-50%.Aspirin was continued an no other further action was taken at that time.Additional follow up  for digital subtraction angiography (dsa) imaging performed on (b)(6) 2019 showed residual aneurysm neck (raymond roy class 2) and parent artery stenosis >50-75%; the patient also experiencing associate symptoms.The patient underwent a retreatment procedure on (b)(6) 2020 in which an additional non-medtronic flow diversion stent was implanted to address the residual aneurysm/residual aneurysm neck.Additional information received reported the treated aneurysm was located in the right carotid artery c7 segment.The aneurysm max d iameter was 12mm and the neck was 12mm.Residual aneurysm/residual aneurysm neck resulted in hospitalization of the patient for retreatment.The patient was hospitalized on (b)(6) 2020 and discharged (b)(6) 2020.The event was not reported to result in any new or worsening neurological deficit.

Manufacturer Narrative

B2.Outcome attributed to adverse event updated based on new information received.B5.Updated with additional information received.Dates corrected in original information submitted based on the new/corrected information received.Additional codes - code added/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 received reported per source, (b)(6) 2019 dsa showed concomitant slight stenosis in origin of a1 segment, contiguous w/implanted stent and slight endoleak at origin of proximal hook of the stent.

• Brand Name: PIPELINE FLEX
• 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: 11527533
• MDR Text Key: 241402400
• Report Number: 2029214-2021-00304
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2019
• Device Model Number: PED-450-25
• Device Catalogue Number: PED-450-25
• Device Lot Number: A359261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• Date Device Manufactured: 10/13/2016
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male