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

Model Number REACT-68

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

Patient Problems Intracranial Hemorrhage (1891); Vascular Dissection (3160); Unspecified Nervous System Problem (4426)

Event Date 04/09/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the patient had a subarachnoid hemorrhage distal to the m2 clot.This was noted during dyna ct before giving anti-platelet treatment.The patient had a minor head injury after a stroke before the index admission.In addition, the final reperfusion mtici score was 0 and there was presence of neurological deterioration at 24 hours post-procedure.The patient had a worsening baseline nihss score.Furthermore, the patient had an expansion of index infarct on the 24 hour post-procedure ct scan.The adverse event was not related to the system or procedure and was not related to the disease under study.In addition the adverse event was not related to an underlying condition or disease.The sponsor assessment determined this was a neurological event of interest.The patient was recovering at the time of the report.The patient was undergoing treatment of the middle cerebral artery, m2.The patient's pre-procedure mtici score was 0 and the final post-procedure mtici score was 0.The patient's baseline mrs was 0 and the patient's nihss score baseline was 15.An iv tpa was contraindicated and 3 passes were made with the device.

Manufacturer Narrative

B5.Updated with additional information received.H6.Patient code (e0515) added based on additional information received.Associated with devices reported in rr #'s: 2029214-2022-00693 2029214-2022-00694 2029214-2022-01022 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 a phenom 21 microcatheter was also used in the procedure.Review of the surgery notes indicated the possibility that the solitaire system was used after dissection had occurred and after use of a non-medtronic device: "diagnostic angiogram performed at 19:15.Changed to react68 - phenom21 - synchro select wire to navigate to the occluded m2.Solitaire x 4mm x 20 mm deployed and solumbra technique performed at 19:33.Second attempt at 19:43 performed using ace 68 -solitaire x 4 x 20.Decided to use solitaire fr 4 x 20 in view of possible icad, which was deployed at 19: 59.Dynact brain performed and at 20:20, the stented segment thrombosed again.In view of sah on ct brain, decided not to given integrilin.Fr stent retrieved at 20:38.Right groin closed with angioseal.".

Event Description

Additional information received reported "craniotomie in the context of secondary hemorrhage" was evident at 24-houre post-procedure ct image.The patient recovered on (b)(6) 2022.The event was possibly related to study procedure and study devices.

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 had recovered/resolved on (b)(6) 2022.It was noted that the neurological e vent of interest, possible related to study procedure and study devices used.On (b)(6) 2022, cec adjudicated event as causal relationship with study procedure, possible to solitaire , react, and mdt ancillary device phenom 21.

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: 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: 14188368
• MDR Text Key: 289901704
• Report Number: 2029214-2022-00692
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K180715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2022
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: B097534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2022
• Date Device Manufactured: 10/06/2020
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 60 KG