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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 Problems Death (1802); Vasoconstriction (2126); Thromboembolism (2654)
Event Date 07/11/2020
Event Type  Death  
Manufacturer Narrative

Refer to manufacturer report 2029214-2020-00736 for details pertaining to the related reportable event. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported the subject had intracranial vasospasm during the procedure. The vasospasm was considered resolved on the same day ((b)(6) 2020), but the subject died the same day due to expansion of the brain injury. During the 24 hour follow-up imaging, it was noted the target clot had embolized to a new vascular territory during the procedure pass number 3; mca m2-l. There was also expansion of the index infarct. The clinical investigator assessed relevancy as probable to the procedure and devices, and the clinical sponsor assessed relevancy as casual to the procedure and probable to the devices.

 
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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 Key10328182
MDR Text Key200486977
Report Number2029214-2020-00737
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK180715
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
Report Date 08/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2020
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
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 Received07/30/2020
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: 07/27/2020 Patient Sequence Number: 1
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