MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR4; CATHETER, THROMBUS RETRIEVER

Model Number SFR4-4-40-10

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

Patient Problems Arrhythmia (1721); Hematoma (1884); Intracranial Hemorrhage (1891); Vascular Dissection (3160)

Event Date 06/21/2021

Event Type  Injury  

Manufacturer Narrative

Event related to regulatory report #: 2029214-2022-01648 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

Medtronic received a report that a patient underwent a combined mechanical thrombectomy procedure in which a react-71 catheter and a solitaire x stent retriever were used to carotid to the right middle cerebral artery (mca) via femoral access.It was unknown if the devices were prepared or the catheter was flushed per instructions for use (ifu).There were no alleged device malfunctions or intra-operative issues.At 24-hour post-procedure on (b)(6) 2021, the site reported observation of hematoma within the ischemic field with space-occupying effect involving more than 30% of the infarcted area (ph2).At discharge on (b)(6) 2021, the site reported subarachnoid hemorrhage (sah).No patient symptoms were noted.Additional information received reported that prior to the procedure the patient's nihss score was 14, at 24 hours post-procedure on (b)(6) 2021 it was 5, and at discharge on (b)(6) 2021 it was 4.The patient's mrs score at discharge was 3.Additional information received reported the site reported the sah as a non-serious adverse event.The patient hospitalization was not prolonged and no additional treatment was required.Additional information received reported medtronic study sponsor assessment concluded the hemorrhagic transformation and sah were possibly related to the index procedure.Additional information received reported a procedure related complication of iatrogenic dissection was evident in the right sub-pet rous ica per the transmitted source procedure report on (b)(6) 2021.No additional treatment was noted.Additional information received reported ph2 hemorrhage was still visible in 90-day follow-up imaging on (b)(6) 2021.Additional information was received indicating the event resolved on (b)(6) 2021.Additional information received reported subject experience asystole during post dilatation balloon inflation treating this event.Sponsor deems asystole procedure related event.Concurrent to the dilatation of the angiography balloon 3x bradycardia/asystole that was treated with 1mg of atropine and 5 chest compressions.After dilatation spontaneous circulation returned.Due to irritation of the carotid artery because of the balloon catheter a bradycardia / asystole is conceivable.Mrs score: 0.Nihss score: 14.The event resolved on (b)(6) 2021.

Event Description

Additional information received reported that 14-jun-2023: the cec adjudicated this event as serious and causal to the study procedure, possible to react aspiration catheter and phenom 21 microcatheter, and not related to solitaire.

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 was received that the hemorrhagic transformation was recovered/resolved with sequelae on (b)(6) 2021.

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: SOLITAIRE FR4
• Type of Device: CATHETER, THROMBUS RETRIEVER
• 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: 15534114
• MDR Text Key: 301158154
• Report Number: 2029214-2022-01649
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K183022
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2022
• Device Model Number: SFR4-4-40-10
• Device Catalogue Number: SFR4-4-40-10
• Device Lot Number: B115401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Date Device Manufactured: 05/26/2020
• 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): Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 98 KG