• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Aspiration/Inhalation (1725); Intracranial Hemorrhage (1891); Cognitive Changes (2551); Embolism/Embolus (4438)
Event Date 01/14/2022
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that a patient undergoing a procedure with a react-71 catheter had stroke conditions impaired level of consciousness. Impaired level of consciousness brings on aspiration pneumonia. Previously reported as distal embolization within the same vascular territory during endovascular procedure. The patient was being treated for a clot in the middle cerebral artery (mca), m1 location. Left hemisphere.  pre-procedure mtici score: 1. Final post-procedure mtici score: 2c.   the patient was hospitalized on (b)(6) 2022. Concomitant treatment was done.   mrs score: 2. Nihss score: 23. The patient died on (b)(6) 2022.  per sponsor assessment event of distal embolism is causal related to procedure and possible to react catheter.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13374255
MDR Text Key284609336
Report Number2029214-2022-00110
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2022
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 NumberB172733
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/09/2021
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: 01/27/2022 Patient Sequence Number: 1
-
-