MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PHENOM; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-FG

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

Patient Problem Arrhythmia (1721)

Event Date 02/27/2020

Event Type  Injury  

Event Description

Medtronic received a report that the pipeline procedure was complicated by 20 seconds of asystole with placement of laryngoscope due to exaggerated vagal response second to regular pyridostigmine for myasthenia gravis.This resolved with the release of the blade pressure and application of topical lignocaine to larynx prior to re-insertion.The site assessed this procedure-related complication was associated with the subject's pre-existing treatment for myasthenia gravis; however, the sponsor was conservatively reporting.Additionally, the procedure notes stated that they exchanged to a neuron 070 guide catheter over a coons exchange length wire.The phenom 0.027" microcatheter and synchro soft microwire were advanced to the left a3 anterior cerebral artery (aca).There was significant instability of the system due to kickback and coiling of the guide catheter within the aortic arch.They upsized to an 8f sheath and converted to a tri-axial approach with a neuronmax 088 guide catheter, navien 058 intermediate catheter, and phenom microcatheter.Per the site, it was unclear if the system instability was due to the anatomy of the aortic arch or the combination of the devices within the system.At the end of the procedure both pipeline stents were successfully deployed. no additional medical intervention was required as minor procedural adjustments seemed to resolve the issues.The patient was undergoing treatment for two unruptured, saccular aneurysms located in the bifurcation branch of the left aca.The first had a dome height of 1mm, width of 1.6mm, max diameter of 3mm, and neck size of 1.7mm.The second aneurysm had a dome height of 2.7mm, width of 4.3mm, max diameter of 4mm, and neck size of 4mm.

Manufacturer Narrative

See manufacturer report #s 2029214-2022-01264 and 2029214-2022-01265 for other devices involved in this event.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 assessed the event as caused by the procedure and not related to the device or antiplatelet medication.Both pipelines had been successfully implanted with neck coverage and wall apposition achieved.

Event Description

Additional information was received reported that the ae was life threatening.

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.

• Brand Name: PHENOM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 15126763
• MDR Text Key: 296846479
• Report Number: 2029214-2022-01266
• Device Sequence Number: 1
• Product Code: KRA
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-FG
• Device Catalogue Number: UNK-NV-FG
• Device Lot Number: UNKONWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 08/23/2022; 10/11/2022
• Supplement Dates FDA Received: 08/31/2022; 11/04/2022
• 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; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Female