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 Hematoma (1884); Pseudoaneurysm (2605)

Event Date 07/22/2023

Event Type  Injury  

Manufacturer Narrative

A separate report will be submitted for the solitaire x device used in the index procedure.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 report that a patient who had undergone a thrombectomy procedure on (b)(6) 2023 in which a react-68 catheter and solitaire x stent retriever were used.Baseline mrs was 0, nihss was 16, and mtici was 0.Tici 2c was achieved in the procedure.On (b)(6) 2023, it was noted the patient had a large hematoma at the right hip.Hemoglobin lab result was 8 g/dl; the patient received a blood transfusion.On (b)(6) 2023, a diagnostic echo doppler of the lower limbs was performed.It was noted there was presence of a circulating right superficial femoral artery pseudoaneurysm.A compressive bandage was applied for 48 hours and the event was noted to be resolved.The events were not life-threatening and did not result in patient disability or prolonged hospitalization.Site assessment concluded the events had a causal relationship to the procedure and an underlying patient condition but was not related to the study device or accessory devices.The medtronic study sponsor assessment concluded conservatively that the events were possibly procedure related.

Manufacturer Narrative

D4.Correct device lot number reported (b525093).No other new information.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 report that a patient who had undergone a thrombectomy procedure on (b)(6) 2023 in which a react-68 catheter and solitaire x stent retriever were used.Baseline mrs was 0, nihss was 16, and mtici was 0.Tici 2c was achieved in the procedure.On (b)(6) 2023, it was noted the patient had a large hematoma at the right hip.Hemoglobin lab result was 8 g/dl; the patient received a blood transfusion.On (b)(6) 2023, a diagnostic echo doppler of the lower limbs was performed.It was noted there was presence of a circulating right superficial femoral artery pseudoaneurysm.A compressive bandage was applied for 48 hours and the event was noted to be resolved.The events were not life-threatening and did not result in patient disability or prolonged hospitalization.Site assessment concluded the events had a causal relationship to the procedure and an underlying patient condition but was not related to the study device or accessory devices.The medtronic study sponsor assessment concluded conservatively that the events were possibly procedure related.

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 was received that the event resulted in surgical procedure.It was noted the event was due to the thrombectomy procedure and that it was not related to an underlying condition or disease.The outcome recovered/resolved date was updated to on (b)(6) 2023.

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

Medtronic received a report that the patient experienced large subcutaneous hematoma on the right hip that was not painful to palpate.The onset date was (b)(6) 2023.The patient fell in his garden before the stroke.Appeared after the thrombolysis.X-ray of the right hup was done after the thrombectomy and result was no fracture.A compressive banding was done.The patient underwent blood transfusion.The patient recovered and the issue resolved on (b)(6) 2023.This adverse event (ae) was not related to the disease under study and probably related to an underlying condition or disease.This ae did not result from a device deficiency.This event led to congenital anomaly, death, disability, hospitalization, and was not considered life threatening.This event resulted in medical intervention.The site assessed this event as not related to the study device or procedure.The sponsor assessed this event as serious adverse event, possibly related to the study procedure.

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 reporting that on (b)(6) 2024 cec adjudicated this event as serious and causal to the study procedure.

• 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: 17539950
• MDR Text Key: 321054980
• Report Number: 2029214-2023-01362
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: B525093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Date Device Manufactured: 02/28/2023
• 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; Other
• Patient Sex: Female
• Patient Weight: 75 KG