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

Model Number PED2-400-16

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Aneurysm (1708); Swelling/ Edema (4577)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the patient's aneurysm occlusion status following a pipeline implant was raymond and roy (r & r) class 3 at their 180 day follow-up imaging.This indicated worsening from the class 2 reported in prior imaging performed post-procedure: no stasis or neck coverage achieved, and wall apposition achieved.Dual antiplatelet therapy (dapt) had been administered during the index procedure.Their 1 year follow up imaging performed on 29-mar-2021 showed aneurysm showed non-occlusion r&r class 3.The patient remained asymptomatic.The patient was treated for a saccular, unruptured aneurysm of the left internal carotid artery terminus.The max diameter was 25mm and the neck diameter was 6mm.The patient's vessel tortuosity was normal.Corelab imaging reported that neck coverage was not achieved at the index procedure on (b)(6) 2020 and all rated follow-up imaging on (b)(6) 2020 and (b)(6) 2021.The site reported neck coverage was not achieved and when queried for possible device deficiency of study device, the site responded it was "due to a recidivism of the aneurysm after the first treatment".The patient underwent surgical retreatment for aneurysm recanalization/recurrence on (b)(6) 2020.They were hospitalized from (b)(6) 2020 to (b)(6) 2020, at which time the recanalization resolved.Corelab imaging reported neck coverage was not achieved at retreatment on (b)(6) 2020 with comment that the pipeline had no aneurysm neck contact.Additionally, corelab reported coil compaction and proximal migration, aneurysm inflow in comparison to treatment at the 1-year follow-up dsa imaging on (b)(6) 2021.Corelab also reported aneurysm occlusion status r&r class 3 at the 2-year follow-up visit on (b)(6) 2022.It was also indicated there was progredient edema around the aneurysm dome.However, the site reported that at their 2-year follow-up mr imaging the aneurysm occlusion status was r&r class 1 with complete neck coverage.

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 confirmed aneurysm recanalization at the patient's 1-year follow-up visit on (b)(6) 2021.The site also reported that the aneurysm occlusion status was class 2 at dsa imaging performed on (b)(6) 2021, and complete obliteration class 1) at the 2-year follow-up mr imaging on (b)(6) 2022.The site confirmed there was no pipeline migration with response, ¿the physician disagree with coil compaction and proximal migration when comparing dsa of (b)(6) 2020 and (b)(6)2021.¿ the site confirmed the neck coverage was not achieved due to aneurysm anatomy with response ¿impossible to cover the enter neck.".

Event Description

Additionally, source note dated (b)(6) 2021, reports subject has had headaches for many years, however states " episodes of headaches that have progressed as acute episodes that last for several hours to several days.The headaches are not necessarily pulsating, sometimes throbbing and sometimes constrictive.Sometimes there is phono or photophobia but no nausea.The pain may be bilateral-frontal, hemicranial or occipital.It is sometimes associated with some cervicalgia.The triggering factors are visual contrasts and stress.".It also notes the subject has a "history of an anxious state which led to psychiatric monitoring and a prescription about six months ago for lamotrigine 100mg.If the acute episodes are significantly frequent in the first quarter of 2021, it seems to have eased for a few months.".Physician comments that they believe the presentation of migraines are no connection to her aneurysm, however, does not exclude any device relationship.

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 agreed with the corelab finding that reperfusion had occurred after retreatment performed on (b)(6) 2020, and therefore the first reported recanalization is considered ongoing.No further treatment has been pl anned as the physician confirmed progressive occlusion of aneurysm.The sponsor assessed the event as possibly related to the procedure, caused by the device, and not related to dapt.

• 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: 14306603
• MDR Text Key: 294663564
• Report Number: 2029214-2022-00784
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/26/2021
• Device Model Number: PED2-400-16
• Device Catalogue Number: PED2-400-16
• Device Lot Number: A759623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Date Device Manufactured: 12/27/2018
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male