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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); Obstruction/Occlusion (2422); Cognitive Changes (2551); Swelling/ Edema (4577)
Event Date 07/04/2020
Event Type  Injury  
Manufacturer Narrative

Patient date-of-birth: only the patient's date of birth was provided; therefore only the year of the reported date-of-birth is valid. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received a report that the patient's nihss score was 17 at 24 h post-procedure. On (b)(6) 2020 it was indicated that the nihss worsened from score 10 reported prior at baseline pre-procedure. Neurological deterioration at post procedure was >= 4 points worsening from baseline nihss scale. Additional information received noted that the patient's neurological deterioration was probably related to the procedure and unlikely related to the device. Additional information received stated that the patient's neurological deterioration was possibly related to the device as consequence of manipulation of the invasive procedure (no hemorrhagic transformation nor edema). On (b)(6), head computer tomography (ct) without contrast was performed with a result of sustained ischemia; however, the patient's had recovered/resolved without sequelae on (b)(6) 2020. Additional information received reported the patient had post-procedure periorbital edema, edema of the conjunctiva and ptosis. Mrs score was 1, nihss score was 10. Right retina central artery occlusion was diagnosed. The events resulted in patient disability and required additional intervention which was not specified. Site assessment reported the events as not related to the solitaire, react catheter, or the procedure. However study sponsor assessment by medtronic concluded the events were possibly related to the procedure.

 
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Brand NameREACT CATHETER
Type of DeviceCATHETER, 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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key11983763
MDR Text Key255663847
Report Number2029214-2021-00721
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK182097
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,S
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberREACT-71
Device Catalogue NumberREACT-71
Device LOT NumberA924890
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/01/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/11/2021 Patient Sequence Number: 1
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