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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 Problem Intracranial Hemorrhage (1891)
Event Date 10/12/2021
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 ct imaging the day after a solitaire procedure contrast retention associated with mild petechial hemorrhagic transformation. There was a hematoma within the ischemic field with mild space-occupying effect involving 30% of infarcted area (ph1). No further treatment or actions were taken. The event was not the result of a device deficiency, and it was noted as recovering/resolving. The patient's mrs score was 0, and their nihss score was 22. The site assessed the event as probably related to the disease under study, not related to an underlying condition, the device, or the procedure. The sponsor assessed the event as possibly related to the procedure. The patient was undergoing treatment for clots located in the a1 segment of the left anterior cerebral artery (aca), the m1 segment of the left middle cerebral artery (mca), a2 segment of the left aca, and the m2 segment of the left mca. The patient's pre-procedure mtici score was 0, and the final post-procedure mtici score was 3. Additional information reported the patient was hospitalized for this event form (b)(6) 2021 until (b)(6) 2022.
 
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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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key13519225
MDR Text Key288798212
Report Number2029214-2022-00209
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberREACT-71
Device Catalogue NumberREACT-71
Device Lot NumberB166008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/29/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/24/2021
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: 02/12/2022 Patient Sequence Number: 1
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