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

Model Number 105-5081-153

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Vasoconstriction (2126); Rupture (2208); Shaking/Tremors (2515); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)

Event Date 07/13/2023

Event Type  Injury  

Event Description

Medtronic received a report that the subject's aneurysm was catharized and while the professor was advancing the artisse inside the rebar, the aneurysm suddenly ruptured.The professor noted possibly due to a change in flow dynamics.The artisse was still inside the rebar and had not yet reached the aneurysm location when the rupture happened.There was a slight forward movement of the microcatheter while pushing the artisse and the movement caused the rupture.The professor subsequently removed the artisse from the rebar and coil the aneurysm to stop the acute bleeding.The patient was admitted to the icu and per current understanding is stable.It was also reported that there was a thrombus at the end of coiling in the m2 branch.Integrilin bolus and infusion was started.The thrombus was resolved at the end.The event resulted in a new or worsening of existing neurological deficits and symptoms lasted for more than 24 hours.The event was treated with a surgical procedure, percutaneous intervention, and concomitant or additional treatment was given, and the event was considered life threatening and resulted in hospitalization.The event was assessed as probably related to the ancilliary device, rebar 18, and a causal relationship to the index procedure.The patient was undergoing surgery for treatment of a saccular, sidewall aneurysm of the right middle cerebral artery with a max diameter of 7.1mm and a 3.8mm neck diameter. complete neck coverage was not achieved at the end of the procedure.

Manufacturer Narrative

Continuation of d10: product id isf-070-030; product type: ; implant date ; explant date , product id unk-nv-rist; product type: ; implant date ; explant date 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 the rupture occurred during the procedure while the subject was under anesthesia.No symptoms reported via the ae crf.Ae description as reported by site, ¿artisse was in the microcatheter when aneurysm rupture occurred.It was never deployed.There was slight forward movement ofthe microcatheter while pushing artisse.That movement caused the rupture.¿ it was noted that the patient recovered/resolved with sequelae (b)(6) 2023.A target aneurysm rupture and thromboembolic event was noted.

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 patient was feeling more tired on on (b)(6) 2023.Imaging revealed vasospasm on the left arteria cerebri anterior proximal part and on the middle cerebral artery (right m2 branch).This caused a prolongation of existing hospitalization, and recovered/resolved on (b)(6) 2023.On (b)(6) 2023 the patient experienced shaking of the right hand.An eeg was performed, and the patient was diagnosed with status epilepticus.This further prolonged the patient's hospitalization and resulted in them being sedated, before recovering/resolving on (b)(6) 2023.The vasospasm and status epilepticus were considered a new or worsening of existing neurological deficit that lasted for more than 24 hours.The site assessed the vasospasm and status epilepticus as caused by the procedure and not related to the devices or the disease under study.Ancillary devices included a sofia intracranial support catheter.

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.

Event Description

Additional information received reported that: cec adj 06oct2023: possibly related to dapt, not related to index procedure, artisse ii, or ancillary device.

Event Description

Additional information received reported the marker provided visual indication of device location inside the microcatheter.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: REBAR
• 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: 17392884
• MDR Text Key: 319718141
• Report Number: 2029214-2023-01174
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K093750
• 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: 04/08/2024

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: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 07/27/2023; 07/25/2023; 08/12/2023; 10/06/2023; 03/28/2024
• Supplement Dates FDA Received: 07/27/2023; 08/14/2023; 08/23/2023; 10/17/2023; 04/08/2024
• 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; Hospitalization; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 74 KG