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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-68
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 01/22/2020
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Raymond sb, nasir-moin m, koch mj, rabinov jd, leslie-mazwi t, patel ab. Initial experience with react 68 aspiration catheter.  interventional neuroradiology: journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences. 2020;26(3):358-363. Doi:10. 1177/1591019919898923 medtronic received a literature article in which the aim of the study was to determine the efficacy of the react-68 aspiration catheter as compared to the ace 68 aspiration catheter. 47 patients were treated using the react catheter using either aspiration alone or a combination of aspiration and stent retriever technique. Of the patients, 31 were male and 16 were female, with an average age of 67 years old. The stent retriever technique was used in cases with very tortuous anatomy that limited advancement of the aspiration catheter, during which a stent retriever was deployed across the occlusion and used as distal support to advance the aspiration catheter while on suction. The catheter was used in a variety of circumstances including proximal and distal occlusions involving the anterior and posterior circulation. Modified tici 2b-3 was achieved in 45 of the 47 patients. A stent retriever was required in 11 patients. The average number of passes was 2, with first pass aspiration achieved in 15 cases. Aspiration alone was achieved in 25 cases, with an average reperfusion time of 22 minutes. An mrs of 0-2 at discharge was seen in 9 patients. Serious intracranial hemorrhage occurred in 2 patients.

 
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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 Key11819836
MDR Text Key251194363
Report Number2029214-2021-00570
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK151638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberREACT-68
Device Catalogue NumberREACT-68
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2021
Was Device Evaluated By Manufacturer? No Answer Provided
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: 05/13/2021 Patient Sequence Number: 1
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