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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 Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Paresis (1998); Dysphasia (2195); Obstruction/Occlusion (2422); Vascular Dissection (3160); Unspecified Nervous System Problem (4426); Respiratory Insufficiency (4462)
Event Date 12/04/2020
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 24 hour follow-up imaging ct imaging showed infarction in a new vascular territory. During treatment, only one pass was made, and the stroke onset to reperfusion time was unknown but final perfusion was (b)(6) 2020 at 03:09. It was also reported there were no patient symptoms or complications associated with the event. The patient was undergoing surgery for treatment of ischemic stroke of the carotid t. The baseline national institutes of health stroke scale (nihss) score was 15, and post-procedure nihss score was 7. The baseline and post-procedure modified thrombolysis in cerebral infarction (mtici) score was 3. The patient had a medical history including atrial flutter or atrial fibrillation, diabetes mellitus, hyperlipidemia, hypertension. Additional information received reported that the initial findings at 24-hour post procedure follow-up of acute infarction of the deep right middle cerebral artery (mca) also showed hyperdense transformation which could correspond with contrast retention and hemorrhagic transformation with compression of the lateral ventricle could not be ruled out. Based on the findings, initiation of anticoagulation treatment was postponed. Follow-up computer tomography perfusion (ctp) was done on (b)(6) 2020 and showed a reduction of the hyperdensity with less compression on the ventricular system. Computer tomography angiography (cta) on (b)(6) 2020 showed resolution of the hyperdensity. However, the patient died on (b)(6) 2020. The events were determined to be caused by the disease under study. Site investigation determined the events were not related to the procedure nor to either medtronic device used. However, medtronic assessment of the event of infarct to new vascular territory determined the event was possibly related to the procedure and the react and solitaire 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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12092802
MDR Text Key259165332
Report Number2029214-2021-00795
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK182097
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 07/23/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberREACT-71
Device Catalogue NumberREACT-71
Device LOT NumberA980852
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 Received07/02/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/22/2020
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: 06/30/2021 Patient Sequence Number: 1
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