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

Model Number PED2-250-14

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Neurological Deficit/Dysfunction (1982); Transient Ischemic Attack (2109); Ischemia Stroke (4418)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event have not been returned for evaluation as they were implanted in the patient.The patient was reported to have some neurological deficit and transient ischemic attack at approximately 24 hours post index procedure.The patient had undergone uneventful pipeline embolization treatment on three aneurysms and there was no report of new or worsening of existing neurological deficits.There was no allegation that the medtronic devices malfunctioned and the direct cause of the event is unknown.Neurological deficits are well known inherent risk that is documented in the instructions for use.Reference mdr# 2029214-2018-01008.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information through clinical study that a cerebrovascular accident has been assessed by site to be possibly related to index procedure.Transient ischemic attack left sided upper and lower limb weakness.The patient was hospitalized > 24 hrs.Ct imaging and 1 hourly neuro obs.Severity was severe.The patient underwent embolization treatment for three aneurysms.The first aneurysm was located in the sidewall saccular left anterior communicating artery.The second aneurysm was located in the right bifurcation branch saccular anterior communicating artery and the third aneurysm was in the right bifurcation branch saccular anterior communicating artery.The reported event did not result in a new or worsening of existing neurological deficits.

Manufacturer Narrative

The additional information received from the investigational site that this likely the contrast leak rather than a hemorrhage.There was note of high volume of iodinated contrast used for treatment of multiple aneurysm in this case.The patient was monitor while in the hospital.There was not any device malfunction or adverse event reported associated with medtronic devices.This event is not meet reporting criteria.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the clinical site that day 2 post op follow up ct of the head revealed no new findings and the previously sulcal hyperdensities and cortical swelling had improved and was barely seen.This event was reported to be likely contrast leak rather than a hemorrhage.There was note of high volume of iodinated contrast used for treatment of multiple aneurysm in this case.The patient was monitor while in the hospital.No other medical intervention was given.This did not result in a new or worsening of existing neurological deficits.

Manufacturer Narrative

Linked with mdr: 2029214-2018-01008.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received indicated the site reported residual neck (b)(6) class 2) was noted in imaging performed on (b)(6) 2019 (aneurysm #2).The site also reported complete occlusion (b)(6)class 1) was noted in imaging performed on (b)(6) 2019 (aneurysm #3).

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.

Event Description

Additional information received indicated that the patient had extensive sulcal hyperdensities at the cerebral cortex with swelling.A diagnostic procedure was performed as a result and the patient's swelling improved.The patient was noted to be recovering/resolving.

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

This event is no longer a reportable event.The pipeline device reported in this event is not marketed in the us and there is no information to suggest malfunction of any pipeline shield device in this event.No additional supplemental mdrs are required unless additional information received indicates a reportable malfunction.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 that the previously described cerebrovascular accident was adjudicated as ischemic stroke possibly related to the procedure and having a causal relationship with the device.This event is no longer a reportable event.The pipeline device reported in this event is not marketed in the us and there is no information to suggest malfunction of any pipeline shield device in this event.No additional supplemental mdrs are required unless additional information received indicates a reportable malfunction.

Event Description

Additional information received reported that the cerebrovascular accident recovered/resolved on 07-nov-2018.

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.

• Brand Name: PIPELINE FLEX W/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: 8122279
• MDR Text Key: 129020082
• Report Number: 2029214-2018-01009
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100018
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2021
• Device Model Number: PED2-250-14
• Device Catalogue Number: PED2-250-14
• Device Lot Number: A647673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Date Device Manufactured: 05/18/2018
• 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): Disability
• Patient Age: 72 YR
• Patient Sex: Male