MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REACT CATHETER; CATHETER, PERCUTANEOUS

Model Number REACT-71

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

Patient Problems Intracranial Hemorrhage (1891); Hydrocephalus (3272); Cerebral Edema (4403); Swelling/ Edema (4577)

Event Date 04/21/2022

Event Type  Injury  

Event Description

Medtronic received a report that the crf imaging 24 hour post a solitaire procedure indicated subarachnoid hemorrhage (sah) and radi ographic mass effect with 3mm midline shift.There were no alleged issues with the device.The patient was undergoing treatment for a a stroke.The stroke onset was on (b)(6) 2022, and the reperfusion time was 07:14 on (b)(6) 2022.The access vessel was radial.Additional information received reported the patient underwent a mechanical thrombectomy procedure in which a solitaire x stent retriever and react-71 aspiration catheter were used.Baseline tici was 0, and tici 2b was achieved in the procedure, mrs was 0.On (b)(6) 2022, mass effect with midline shift of 3mm was observed in post-operative ct.Follow-up ct on (b)(6) 2022 should midline shift of approximately 7mm to the left.Mass effect with obliteration of sulci was accompanied by early signs of hydrocephalus.The event was noted to be life-threatening though there was no reported additional medical intervention, patient disability, or prolonging of patient hospitalization.The event was noted to probably be related to the patient disease under study and to the procedure but was not related to the solitaire device or react aspiration catheter, per site assessment.The patient was noted to be recovering and the event resolving.

Manufacturer Narrative

(b)(6), therefore, only the year of the reported date-of-birth is valid.Associated with rr #: 2029214-2022-00928.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported nihss was 23.

Manufacturer Narrative

B5.Updated with additional information received.Associated with rr #: 2029214-2022-00928.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 ct imaging showed the patient had a brain edema and the sah was located in the right f ronto-parietal and ipsilateral sylvan.The sah and brain edema had not recovered or resolved.There was hemorrhagic transformation (ph2) in hemoventricle in the right ventricle.The event was not the result of a device deficiency, and resulted a prolongation of ho spitalization.It was not a new or recurrent stroke.The site assessed the sah as caused by the procedure, not related to the device, and possibly related to the disease under study.The site assessed the brain edema as not related to the device and possibly relat ed to the procedure and the disease under study.The site assessed the sah and brain edema as procedure related.The patient had been undergoing treatment for a clot located in the right internal carotid artery below the carotid t.The patient's pre-procedure mtici score was 0, and post-procedure it was 2b.Ancillary devices include a 5x31 embotrap.

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 cec assessed event as non-serious, possible related to study procedure and device solitaire.Midline shift of approximately 7 mm to the left.

• Brand Name: REACT CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 14573449
• MDR Text Key: 293311346
• Report Number: 2029214-2022-00929
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K182097
• 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
• Report Date: 09/25/2023

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 Expiration Date: 11/01/2023
• Device Model Number: REACT-71
• Device Catalogue Number: REACT-71
• Device Lot Number: B292616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 06/27/2022; 09/21/2022; 09/14/2023
• Supplement Dates FDA Received: 07/07/2022; 09/29/2022; 09/25/2023
• Date Device Manufactured: 11/04/2021
• 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): Life Threatening; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male