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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 REACT CATHETER; CATHETER, PERCUTANEOUS Back to Search Results
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.
 
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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 Key14573449
MDR Text Key293311346
Report Number2029214-2022-00929
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K182097
Number of Events Reported1
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 Date11/01/2023
Device Model NumberREACT-71
Device Catalogue NumberREACT-71
Device Lot NumberB292616
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/26/2022
Initial Date FDA Received06/02/2022
Supplement Dates Manufacturer Received06/27/2022
09/21/2022
09/14/2023
Supplement Dates FDA Received07/07/2022
09/29/2022
09/25/2023
Date Device Manufactured11/04/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Hospitalization;
Patient Age82 YR
Patient SexMale
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