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

Model Number NV UNK PIPELINE

Device Problem Activation Failure (3270)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Linked with mdrs: 2029214-2020-00579.If information is provided in the future, a supplemental report will be issued.

Event Description

Yuan-hsiung tsai, ho-fai wong, shih-wei hsu.¿endovascular management of spontaneous delayed migration of the flow-diverter stent¿ h ttps://doi.Org/10.1016/j.Neurad.2018.11.004.Spontaneous delayed migration of the fd was identified and treated in 6 patients.Two of them had distal migration of the fd, while 4 others had proximal migration of the device.All the patients were female, ranging in age from 41 to 74 years old.All the aneurysms were in the distal internal carotid artery (ica), with the longest diameter ranging from 0.8 to 3.0 cm.All fds were deployed with a tri-axial system.Additional coiling was performed in 4 cases using the jailed micro-catheter technique.Technical success of device deployment was achieved in all 6 patients, with an immediate contrast stasis within the aneurysm and an adequate stent position confirmed by cone-bean ct.After initial treatment by fd, one patient (patient no.1) suffered from temporal lobe infarction due to distal stent migration to the orifice of the anterior temporal artery.Another patient (patient no.6) suffered from intermittent headache after the procedure.Newly deposited leptomeningeal haemosiderin was noted by mri at the 8th month after the procedure, and subarachnoid hemorrhage (sah) was considered.Regarding the delayed migration of the fd, three patients were treated with a 2nd or 3rd fd, 2 were treated with stent-assisted coiling, and one was treated with sacrifice of the parent internal carotid artery (ica).Complete occlusion of the aneurysm was noted during follow-up in 4 patients, while 2 patients only achieved partial obliteration of the aneurysm.Patient 3.A 69-year-old woman suffered from left abducent nerve palsy for several years.Mri and dsa showed a giant fusiform ica aneurysm at the cavernous segment.The aneurysm measured 3.0 × 2.1 cm.The diameter of the inflow vessel was 4.0 mm, and the diameter of the outflow vessel was 3.7 mm.The patient received a dual anti-platelet regimen for 5 days prior to treatment.With the use of a tri-axial system, a 4 × 25 mm ped was deployed across the aneurysm.Immediately after stent deployment, dsa and cone-beam ct showed adequate stent coverage of the aneurysm with contrast stasis in the aneurysm sac.The middle part of the stent did not expand well and was likely stretched due to compression by the aneurysm, without significant disruption of the flow to the distal ica and middle cerebral artery (mca).Coiling with the jail technique was performed following deployment of the ped.The patient was neurological ly intact after the procedure.However, follow-up dsa at 6 months revealed proximal migration or retraction of the ped with direct flow from the unprotected neck to fill the aneurysm sac.Due to the long aneurysmal neck, tortuous patent artery and incomplete stent expansion, poor endothelialization with herniation of the fd into the aneurysm was considered to be the reason of 6th word: through not though, please change migration.We tried to pass though the ped and the aneurysm by navigating a microcatheter but failed due to a small calibre and very tortuous ica along the wall of the aneurysm.Thus, the decision was made to deconstruct the parent artery.A balloon test occlusion was performed and revealed good crossover of the left anterior cerebral artery and mca from the right ica.The left ica was then successfully occluded with a combination of coils and onyx 18.A control cerebral angiogram showed no filling of the left ica or aneurysm.

Manufacturer Narrative

Review of this event found that the event was previously reported in reports 2029214-2019-00195, 2029214-2019-00196, 2029214-2019-00197, and 2029214-2019-00198.Therefore, any additional information pertaining to this article and event will be submitted under those reports.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
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10182199
• MDR Text Key: 217326851
• Report Number: 2029214-2020-00580
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: NOT- REP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other