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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 Physical Resistance/Sticking (4012)
Patient Problems Cardiac Arrest (1762); Death (1802); Stenosis (2263); Insufficient Information (4580)
Event Date 10/02/2020
Event Type  Death  
Manufacturer Narrative

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

 
Event Description

Medtronic received a report that the physician felt significant resistance while removing the react, velocity, and infinity. It was noticed after moving the react, there was a distal ring remaining in the anatomy. Right vert 6-7 mm into right vert two hairpin turns. In the middle of the turns, there was a significant restriction/stenosis in the origin of thevert. An attempt was made to retrieve with a 4 mm gooseneck snare. The patient went into cardiac arrest and died shortly after. The physician stated they did not believe the patient's death was related to the mechanical thrombectomy. The patient had a history of high blood pressure and a-fib. The patient was undergoing surgery for stroke due to thrombus.

 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10662375
MDR Text Key210986899
Report Number2029214-2020-01016
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/12/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberREACT-71
Device Catalogue NumberREACT-71
Device LOT NumberNOT-REP
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/20/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2020
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: 10/12/2020 Patient Sequence Number: 1
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