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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 Aspiration/Inhalation (1725); Stroke/CVA (1770); Hematoma (1884); Intracranial Hemorrhage (1891); Multiple Organ Failure (3261); Swelling/ Edema (4577)
Event Date 05/14/2021
Event Type  Death  
Manufacturer Narrative

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

 
Event Description

Medtronic received information reporting that a patient underwent a combined mechanical thrombectomy procedure to collect thrombus in the left middle cerebral artery (mca) m1 segment. In which a solitaire device, react-68 catheter, and phenom 27 microcatheter were used. The patient's baseline nihss was 17, baseline mtici was 0, and aspect was 8. All devices were prepared as indicated in the instructions for use (ifu) and the catheter was flushed per ifu.  no device malfunction or intra-operative issues were reported. Final mtici score was 2c.  24-hour post-procedure computed tomography (ct) on (b)(6) 2021 revealed expansion of the index infarction with mild space-occupying effect 30% or less of the infarcted area (ph1). Nihss at 24-hours post-procedure was 13. Ct performed at discharge on (b)(6) 2021 showed hematoma within the ischemic field with mild space-occupying effect involving more than 30% of the infarcted area (ph2) and "malignant cerebral edema/brain edema". Nihss score at discharge was 13. No additional treatment was noted. Additional information received indicated the patient was discharged (b)(6) 2021 with an modified rankin scale (mrs) score of 4, and baseline nihss was 17. The model/lot # of the phenom microcatheter was not collected in the study. Additional information received reported that ct imaging the day after a solitaire procedure showed expansion of ischemic parenchyma and hemorrhagic transformation in the basal ganglia. The stroke and need for hospitalization lead to aspiration pneumonia and multiple organ failure. The patient's mrs score was 0 and their nihss score was 17. The patient later passed away on (b)(6) 2021. The event was not the result of a device deficiency. The event was assessed as probably related to the disease under study, caused by an underlying condition/disease, not related to the device, and probably related to the procedure. The patient had been undergoing treatment for a clot located in the m1 segment of the left middle cerebral artery. The patient's mtici score pre-procedure was 0, and post-procedure it was 2c.

 
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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 Key12097442
MDR Text Key259313490
Report Number2029214-2021-00797
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeGR
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 09/29/2021
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-68
Device Catalogue NumberREACT-68
Device LOT NumberB099684
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 Received09/03/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/09/2020
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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